Trinity Biotech 2346581

• FDA 510(k) K033083 decided 26 Nov 2003 Active
• FDA GUDID UDI-DI 05391516747486 listed 5 Nov 2019 Listed

1. 26 Nov 2003 Cleared FDA 510(k) K033083
2. 5 Nov 2019 Listed FDA GUDID 05391516747486

Trade name

Trinity Biotech

Generic name

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

Model / Ref / Catalog

2346581

Primary DI / UDI-DI

05391516747486

510(k) Number

K033083 ↗

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

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

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• BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT by Boston Biomedica, Inc.
• QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 by Immunetics, Inc.

• 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. →