ORTHO-CLINICAL DIAGNOSTICS

9 devices in the database

  • Model / Serial
    Lot 3082, expiry date 7/27/2015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
  • Model / Serial
    Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. || For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
  • Model / Serial
    Lot Numbers:1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda
  • Product Description
    VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, || For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
  • Model / Serial
    Lot numbers: 1470 (expiry date 02-Aug-16); 1480 (expiry date 05-Aug-16), 1490 (expiry date 10-Oct-16), 1500 (expiry date 10-Oct-16), 1510 (expiry date 01-Nov-16), 1528 (expiry date 01-Nov-16) 1538 (expiry date 14-Mar-17), 1548 (expiry date 09-Mar-17), 1558 (expiry date 09-Mar-17) and 1568 (expiry date 29-Mar-17)
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Puerto Rico, and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, Venezuela.
  • Product Description
    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
  • Model / Serial
    Lot 5040 (Expiry date 19 Dec 2016)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
  • Product Description
    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK || For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
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