Ortho-Clinical Diagnostics

7 devices in the database

  • Model / Serial
    Lot #750, Exp. 14 January 2004
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J; International Affiliates for further distribution to foreign users. Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.
  • Product Description
    Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
  • Model / Serial
    Lot 611, Exp. 25 June 2004
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.
  • Product Description
    Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
  • Model / Serial
    All lots with an expiration date of 1June 2005 and earlier.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide distribution to distributors and end-users.
  • Product Description
    Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.]
  • Model / Serial
    All lots with an expiration date of 1 December 2004 and earlier.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide distribution to distributors and end-users.
  • Product Description
    Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]
  • Model / Serial
    All slide lots with coatings ''0292'' and ''0293''. The coating lot numbers are seen as ''xxxx-0292-xxxx'' and ''xxxx-0293-xxxx'' in the lot number.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide.
  • Product Description
    Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
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