Trinity Biotech 40-1013

• FDA 510(k) K892206 decided 15 Aug 1989 Active
• FDA GUDID UDI-DI 05391516747547 listed 6 Aug 2019 Listed

1. 15 Aug 1989 Cleared FDA 510(k) K892206
2. 6 Aug 2019 Listed FDA GUDID 05391516747547

Trade name

Trinity Biotech

Generic name

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Model / Ref / Catalog

40-1013

Primary DI / UDI-DI

05391516747547

510(k) Number

K892206 ↗

FDA product code

LSR

GMDN term

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Device class

Class II

Regulation number

866.3830

GUDID distribution status

In Commercial Distribution

Size

Total Volume — 100 Milliliter

Category: Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

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• Trinity Biotech 2325760

  Class I

  CE/IVDD FDA 510(k) K980596 Active Cleared 22 Jul 1998 +1authorizations

• Trinity Biotech 2325950

  Class I

  GUDID on market

• Bio-Rad Platelia 72938

  Class I

  CE/IVDD FDA 510(k) K973123 Active Cleared 26 Mar 1998 +1authorizations

• Trinity Biotech 2325460

  Class II

  CE/IVDD GUDID on market

See all devices from Clark Laboratories, Inc. →