Clark Laboratories, Inc. (dba,Trinity Biotech USA)

2 devices in the database

  • Model / Serial
    Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the state of WA
  • Product Description
    Captia Syphilis-G Test Kit || Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
  • Model / Serial
    Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
  • Product Description
    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. || For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Rd, Jamestown NY 14701-9666
  • Manufacturer Parent Company (2017)
  • Source
    USFDA