IMMULITE/IMMULITE 1000

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    MHSIDCCCDMIS

42 devices with a similar name

Learn more about the data here

  • Model / Serial
    Kit lots 0333 and 0334 (OUS)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries: Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.
  • Product Description
    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- || For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
  • Manufacturer
  • Model / Serial
    Kit lots 236M, 237, 238, 239, 239L (OUS) and D236M and D238 (US)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries: Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.
  • Product Description
    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- || For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
  • Manufacturer
  • Model / Serial
    All lots LKPS1/LKPS5 - Lots 443, 445, 446 LKPTS1 - Lot D116
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Great Britain, Grenada, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, South Africa, South Korea, Suriname, Switzerland, Syria, Taiwan, Tadjikistan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK || For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi 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.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 1) 0336 - Expiration date 2017-01-31 2) 0337 - Expiration date 2017-02-28 3) 0338 - Expiration date 2017-05-31
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 1) D01196 - Expiration date 2016-12-31 2) D0120 - Expiration date 2017-03-31
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany
  • Product Description
    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.
  • Manufacturer
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