IsSyphilis TREPCHEK Test Kit.

  • Modèle / numéro de série
    The kit lot number is 42003. The conjugate lot number is 42023.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to 54 laboratory accounts throughout the US.
  • Description du dispositif
    The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. || The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Diamedix Corporation, 2140 N Miami Ave, Miami FL 33127-4916
  • Source
    USFDA