DRG Instruments Gesellschaft mit beschränkter Haftung

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ANTIGENS, ALL, LEPTOSPIRA SPP. (GRY) (1)

Premarket Exempt

No Yes

Clear

Leptopspira IgG ELISA - 04048474057515 Catalog Number : EIA-5751

Device Description : The Leptospira IgG ELISA is intended for the qualitative determination of IgG cl The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human serum or plasma (heparin).

Device Class : 2

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GRY

Prescription Use : Yes

Device Count : 1

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