Trinity Biotech 2346580

• FDA 510(k) K033083 decided 26 Nov 2003 Active
• FDA GUDID UDI-DI 05391516747189 listed 19 Sep 2016 Listed

1. 26 Nov 2003 Cleared FDA 510(k) K033083
2. 19 Sep 2016 Listed FDA GUDID 05391516747189

Trade name

Trinity Biotech

Generic name

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

Model / Ref / Catalog

2346580

Primary DI / UDI-DI

05391516747189

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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• LYME STAT TEST KIT by Whittaker Bioproducts, Inc.

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  Class I

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• Trinity Biotech 2325950

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  GUDID on market

• Bio-Rad Platelia 72938

  Class I

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• Trinity Biotech 2325460

  Class II

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