Bordier affinity products S.A.

Address:Chatanerie 2,Crissier Vaud,CH

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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

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (KHW) (1) Device, General Purpose, Microbiology, Diagnostic (LIB) (1) Elisa, Trichinella Spiralis (MDT) (1) Reagents, Cysticercosis (MDJ) (1)

Premarket Exempt

Yes

Clear

Fasciola hepatica IgG ELISA - 07640158219652 Catalog Number : 9650

Device Description : The Fasciola hepatica ELISA test is a qualitative enzyme immunoassay for the det The Fasciola hepatica ELISA test is a qualitative enzyme immunoassay for the detection of Fasciola hepatica antibodies in human serum samples.

Device Class : 2

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : KHW

Prescription Use : No

Device Count : 1

Taenia solium IgG ELISA - 07640158219706 Catalog Number : 9700

Device Description : The Taenia solium ELISA test is a qualitative enzyme immunoassay for the detecti The Taenia solium ELISA test is a qualitative enzyme immunoassay for the detection of Taenia solium antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : MDJ

Prescription Use : No

Device Count : 1

Trichinella spiralis IgG ELISA - 07640158219751 Catalog Number : 9750

Device Description : The Trichinella spiralis ELISA test is a qualitative enzyme immunoassay for the The Trichinella spiralis ELISA test is a qualitative enzyme immunoassay for the detection of Trichinella spiralis in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : MDT

Prescription Use : No

Device Count : 1

Anisakidae IgG ELISA - 07640158219805 Catalog Number : 9800

Device Description : The Anisakidae ELISA test is a qualitative enzyme immunoassay for the detection The Anisakidae ELISA test is a qualitative enzyme immunoassay for the detection of Anisakidae antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : LIB

Prescription Use : No

Device Count : 1

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