Vitros

  • Model / Serial
    All Vitros ECi units currently on the market (software version 3.1 or lower).
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
  • Product Description
    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA

888 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot 710, Exp. 7/28/05
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution. Product shipped worldwide via J&J; foreign affiliates.
  • Product Description
    VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
  • Manufacturer
  • Model / Serial
    Generations 18, 19, 20, 21, and 23
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    423 U.S. consignees nationwide, and 22 OCD/J&J; foreign affiliates (Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain)
  • Product Description
    Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.
  • Manufacturer
  • Model / Serial
    01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped nationwide and to Ortho-Clinical/J&J; affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.
  • Product Description
    VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.
  • Manufacturer
  • Model / Serial
    Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to end users (medical facilities, testing labs and public health agencies). One J&J; foreign affiliate in Puerto Rico with sub-distribution in the Caribbean.
  • Product Description
    Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.
  • Manufacturer
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