Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102

Immunology and Microbiology Devices

2

No

US Nationwide Distribution.

Great Basin Staph lD/R Blood Culture Panel || The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.

Lot Numbers: 1) 0336 - Expiration date 2017-01-31 2) 0337 - Expiration date 2017-02-28 3) 0338 - Expiration date 2017-05-31

Immunology and Microbiology Devices

3

No

Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany

IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) || Product Usage: || For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

Lot Numbers: 1) D01196 - Expiration date 2016-12-31 2) D0120 - Expiration date 2017-03-31

Immunology and Microbiology Devices

3

No

Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany

IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) || Product Usage: || For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

Lot #401413

Immunology and Microbiology Devices

2

No

U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.

Optilite IgG4 Kit || Product Code: LK009.OPT.A

161028133653JH, 161003111544KH, and 161007105036JG

Immunology and Microbiology Devices

2

No

Nationwide throughout the US

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

All G8's with Reporting Software interfaced with LIS.

Immunology and Microbiology Devices

2

No

US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.

Keyspan High-High Speed USB to Serial Adapter || Product Usage: || The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.

Reference no. 506758, Lot #1003693010, 003922720, 003945330, 004193850, 004325620, 004427220, 004510540, 1004720640 & 1004830190 and Reference no. 506718, Lot #1003788640, 1003823960, 1003945320, 1004427210, 1004510360, 1004719300 &1004830170.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 503558, Lot #1003158260 and Reference no. 503518, Lot #1003161140.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 412302, Lot #1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200 & 1004876830 and Reference no. 412303, Lot # 1002939450, 1003089900, 1003813690, 1003851120, 1003953500, 1004152070, 1004315690, 1004394520, 1004525320, 1002939450, 1003089900, 1004755940, 1004828440, 1004876840 & 1005118100.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 508650, Lot #1001060450, 1001154650, 1001212890, 1001264540, 1001319180, 1001390080, 1001390440, 1001409510, 1001409520, 1001441760, 1001540660, 1001589490, 1001621240 & 1001656460; Reference no. 508658, Lot #1001093880, 1001154820, 1001265110, 1001319480, 1001390570, 1001441910, 1001487610, 1001647880, 1001708510, 1001811360, 1002041010, 1002102920, 1002435570, 1002567240, 1002725010, 1003246020, 1003889730, 1004168400, 1004364330, 1004491220 & 1004939670; Reference no. 508610, Lot #1001026950, 1001199360 1001427690, 1001518090, 1001595490, 1001740320 & 1001989260 and Reference no. 508618, Lot #1001032350, 1001242030, 1001338050, 1001416820, 1001471720, 1001595500, 1001627650, 1001720440, 1001728140, 1001786480, 1001956220, 1002109250, 1002338880, 1002435190, 1002566960, 1002718380, 1002975330, 1003886270, 1003894060, 1003981160, 1004064990, 1004075190, 1004168390, 1004490810 & 1004939640.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 525550, Lot #1001094650, 1001136230, 1001212920, 1001293800, 1001302920, 1001319720, 1001334090, 1001391310, 1001430030, 1001518060 & 1001686190; Reference no. 525558, Lot #1001174720, 1001251340, 1001334100, 1001368020, 1001442000, 1001566840, 1001647970, 1001734920, 1001761450, 1001761480, 1001897000, 1001898600, 1002008040, 1002073480, 1002197270, 1002282890, 1002338820, 1002365880, 1002443950, 1002465840, 1002558040, 1002562240, 1002733640, 1002751340, 1003171920, 1003449250, 1003679000, 1003836080, 1004040220, 1004121870, 1004151340, 1004173130, 1004256780, 1004264340, 1004371500, 1004491190, 1004509340, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320, 1005186480, 1004735790, 1004767430, 1004775900, 1004914010, 1004980280, 1005027180 & 1005132340; Reference no. 525510, Lot #1001051200, 1001125840, 1001416930, 1001455150, 1001548250 & 1001596090 and Reference no. 525518, Lot #1001192860, 1001223460, 1001317000, 1001338170, 1001416940, 1001416950, 1001492590, 1001566860, 1001634070, 1001728340, 1001761460, 1001887350, 1001894800, 1002007990, 1002045080, 1002113290, 1002197250, 1002287970, 1002338070, 1002369060, 1002440920, 1002463490, 1002496690, 1002565090, 1002583690, 1002604690, 1002663860, 1002809200, 1002809880, 1002876470, 1002922750, 1003079740, 1003134480, 1003373510, 1003621540, 1003778630, 1003809630, 1003910700, 1003972790, 1004052410, 1004121860, 1004150380, 1004256770, 1004371490, 1004496990, 1004508060, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320 & 1005186480.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 535958, Lot #1004265390 & 1005138210 and Reference no. 535918, Lot #1003902400, 1004103780, 1004266960, 1004867770.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 502558, Lot #1003036730, 1003142000, 1003191650, 1003408580, 1004047410, 1004139950, 1004242300, 1004539350 1004783810, 1004872380, 1004910650 & 1004985540 and Reference no. 502518, Lot #1002911350, 1002964350, 1003012790, 1004047370, 1004140000, 1004244180, 1004420440, 1004539950, 1004783760, 1004872350, 1004896600.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 529140, Lot #1001390510, 1001441860, 1001609400, 1001733320, 1001761030, 1001920530, 1001966610, 1002009360, 1002084930,  1002106570, 1002158050, 1002168110, 1002395840, 1002452170, 1002500020, 1002604960, 1002992250, 1003030810, 1003127520, 1003274260, 1003322150, 1003412730, 1003535930, 1003678890, 1003800400, 1004100220, 1004177630, 1004365540, 1004410620, 1004557900, 1004703240, 1004783050, 1004838760, 1005034320, 1005097790, 1005151830; Reference no. 529148, Lot #1001368050, 1001442030, 1001566960, 1001578760, 1001708630, 1001833500, 1001894590, 1001920200, 1001955170, 1002084950, 1002172820, 1002226550, 1002410940, 1002451250, 1002501640, 1002604970, 1002964340, 1002992260, 1003121770, 1003274280, 1003491070, 1003526920, 1003626710, 1003743380, 1003946090, 1004037330, 1004273540, 1004323330, 1004557890, 1004593710, 1004696420, 1004790240, 1005031600, 1005098130, 1005151890 & 1005151920; Reference no. 529100, Lot #1001324170, 1001378120, 1001403920, 1001433710, 1001472010, 1001487340, 1001517680, 1001535750, 1001567600, 1001617880, 1001621170, 1001702730, 1001707190, 1001726300, 1001761020, 1001879240, 1001927370, 1001976740, 1001998470, 1002123080, 1002160660, 1002391350, 1002449230, 1002487920, 1002551790, 1002614480, 1002705810, 1002786510, 1002890670, 1002960380, 1002992220, 1003030800, 1003181900, 1003274090, 1003491050, 1003836110, 1004100080, 1004137920, 1004273550, 1004381380, 1004593700, 1004629890, 1004631880, 1004851860, 1005034300, 1005192380 & 1005261410 and  Reference no. 529108, Lot #1001324180, 1001370190, 1001482570, 1001527650, 1001567610, 1001634260, 1001744620, 1001829580, 1002044710, 1002090510, 1002175950, 1002223920, 1002392160, 1002449900, 1002494590, 1002565460, 1002615530, 1002706050, 1002785800, 1002960400, 1002992240, 1003099530, 1003182230, 1003322130, 1003404520, 1003491000, 1003526910, 1003580860, 1003629820, 1003876820, 1004022140, 1004177620, 1004323320, 1004576570, 1004680780, 1004941770, 1005098120, 1005212770 & 1005302500.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 513610, Lot #1001125240 & 1001610770; Reference no. 513618, Lot #1001193130, 1001223300, 1001316710, 1001377740, 1001454060, 1001454090, 1001527340, 1001633670, 1001721100, 1001801280, 1001804930, 1002029820, 1002234950, 1002238110, 1002269280, 1002476170, 1002593870, 1002699130, 1002702380 & 1003066070; Reference no. 513658, Lot #1001154880, 1001265150, 1001368000, 1001390590, 1001487630, 1001609830, 1001676400, 1001735190, 1001811380, 1002056670, 1002230910, 1002478800, 1002596830 & 1003066090 and Reference no. 513650, Lot #1001135740, 1001154700, 1001251110, 1001319240, 1001333960, 1001409550, 1001557360, 1001574370.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 512550, Lot # 1002001100 & 1002048740; Reference no. 512510, Lot #1001970170 & 1002154750; Reference no. 512558, Lot #1001564260, 1001676270, 1001733240, 1001793760, 1001873760, 1002113320, 1002230930, 1002559800, 1002823250, 1002113320, 1002230930, 1002559800, 1002823250, 1003495040, 1003883840, 1004248160, 1004252230, 1004277880, 1004567040, 1004946070, 1004980260, 1005146190, 1003495040, 1003883840, 1004248160, 1004252230, 1004277880, 1004567040, 1004946070, 1004980260 & 1005146190 and Reference no. 512518, Lot #1001595660, 1001707960, 1001803880, 1002094250, 1002229210, 1002233690, 1002559790, 1002684500, 1002823910, 1003164040, 1003191670, 1003279330, 1003604650, 1004047450, 1004157400, 1004247950, 1004252220, 1004528390 & 1004567000.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 522718, Lot #1001761650, 1002112440, 1002860460 & 1005166530 and Reference no. 522758, Lot #1001888970, 1002281590 & 1003590490.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Reference no. 507058, Lot #1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030 and Reference no. 507018, Lot #1002940880, 1003182290, 1003813700, 1003851130, 1003953490, 1004239880, 1004316460, 1004527210, 1004755930, 1004828450, 1004876850 & 1004919010.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

REF: #412590, Lot: Software version 1.1.4

Immunology and Microbiology Devices

2

No

U.S.

VIDAS 3 software v. 1.1.4

REF 412304 - 1004497830; REF 412305 - 1002884720, 1003028270, 1003075500, 1003383650, 1004018820, 1004497810, 1005161160; REF 506918 - 1002884980, 1003028290, 1003075850, 1003385930, 1003396150, 1004022170, 1004498100, 1005161470; REF 506958 - 1002885010, 1003075540, 103396550, 1004019050, 1004501930, 1005161480

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US including AZ, AR, CA, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI, and Internationally to Algeria, United Arab Emirates, Austria, Australia, Brazil, Cambodia, Canada, Chile, Chine, Costa Rica, Croatia, Czech Republic, Ecuador, Estonia, France, Greece, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uruguay, and Vietnam

ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria

PS10171

Immunology and Microbiology Devices

2

No

Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX

Influenza Transport Swab Packages, Reference #20171, || One lot with 1010 packages (each package contains 25 transport tubes). || The Influenza Swabs in dry transport tubes are intended for use with influenza tests

EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C

Immunology and Microbiology Devices

2

No

Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None

EliA Sample Diluent, Article number, 83-1023-01

A) Lot: 978596, 2017-01-30; B) Lot: 978948, 2017/01/30

Immunology and Microbiology Devices

2

No

USA ( nationwide ) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and WY.

Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,

Catalog Number Batch Number  446252 5126980  5135673  5138774  5140625  5142767  5153674  5153675  5224882  446257 5141655  5148857  5156873  5173648

Immunology and Microbiology Devices

1

No

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and to the countries of : AU, BE, IN, KR, SG,

BD AffirM VPIII Microbial Identification Test

Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850

Immunology and Microbiology Devices

2

No

Product was distributed to three testing laboratories in California, New Jersey and Virginia

Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.