Lin-Zhi International Inc

8 devices in the database

  • Model / Serial
    Catalog #A68825, Lot #1307086; Exp. 3/28/2014/
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution in CA.
  • Product Description
    Single Analyte Urine DAU Control (5 m L || Norbuprenorphine, Level II control || For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. || Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. || Manufacturer: || Lin-Zhi International, Inc. || 670 Almanor Ave. || Sunnyvale, CA 94085 || The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
  • Model / Serial
    Catalog 0804; lot number 1101138K2, exp 1/28/2013
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of NC,MA, NH and TX. and the country of Germany,
  • Product Description
    Multi-Analyte Urine DAU Calibrator (15 mL); || Multi-Analyte,Intermediate Calibrator; || for in-vitro diagnostic use only. || Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. || Drug abuse testing || Lin-Zhi International, Inc.' || 670 Almanor Ave. || Sunnyvale, CA 94085.
  • Model / Serial
    Large Kits Catalog number 0141, lot # 1105052, exp 11/25/12; small kits catalog number 0140, lot # 1105053, exp 11/25/12.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AL, CA, FL, IN, MA, NC, NH, TX and the countries of: Germany and United Kingdom.
  • Product Description
    Barbiturate Enzyme Immunoassay; R1 || Antibody/Substrate Reagent (5000 tests and 500 tests); || Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. || and Barbiturate Enzyme Immunoassay R2; || Enzyme Conjugate Reagent (5000 tests and 500 test packaging); || Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. || For in-vitro diagnostic use only. || Lin-Zhi International Inc. || 670 Almanor Ave., || Sunnyvale, CA 94085 || Product Usage: Drug testing
  • Model / Serial
    Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including CA.
  • Product Description
    Single Analyte DAU Calibrator (5 mL) || Norbuprenorphine: Cutoff Calibrator; || IVD - for in vitro diagnostic use only; || Lin-Zhi International || Sunnyvale, CA || The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
  • Model / Serial
    Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
  • Product Description
    Cannabinoids DAU Calibrator Control Level 1 || (62.5 ng/mL) || This solution is prepared from non-sterile urine and should be handled as potentially infectious. || IVD; || The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free || matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿¿ 10% by GC/MS or LC/MS analysis. || Lin Zhi International inc. || Sunnyvale, CA 94085 || The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
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