MarDx 40-8696P/J

• FDA 510(k) K892206 decided 15 Aug 1989 Active
• FDA GUDID UDI-DI 05391516746618 listed 7 May 2017 Listed

1. 15 Aug 1989 Cleared FDA 510(k) K892206
2. 7 May 2017 Listed FDA GUDID 05391516746618

Trade name

MarDx

Generic name

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

Model / Ref / Catalog

40-8696P/J

Primary DI / UDI-DI

05391516746618

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

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

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  GUDID on market

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  Class I

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See all devices from Clark Laboratories, Inc. →