Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003718445

FEI Number

3003718445

Entity Name

BORDIER AFFINITY PRODUCTS SA

City/State/Country

Crissier Vaud, CH

Establishment Address

Chatanerie 2, Batiment Biokema, Crissier Vaud 1023, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bordier Affinity Products (Owner Number: 10042667)

Owner / Operator Contact Address

Chatanerie 2, Batiment Biokema, Crissier, CH-VD 1023, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Echinococcus multilocularis (Em18) IgG ELISA Echinococcus granulosus IgG ELISA Echinococcus multilocularis (Em2-Em18) IgG ELISA Schistosoma Mansoni IgG ELISA Ascaris IgG ELISA Strongyloides ratti IgG ELISA Trichinella spiralis IgG ELISA Aspergillus fumigatus IgG ELISA Taenia solium IgG ELISA Toxocara canis IgG ELISA Entamoeba histolytica IgG ELISA Fasciola hepatica IgG ELISA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2012-12-17
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Microbiology	Class 1	866.3600	2012-12-17
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2012-12-17
JWT	Antigen, Cf, Aspergillus Spp.	Microbiology	Class 1	866.3040	2022-09-20
MDJ	Reagents, Cysticercosis	Microbiology	Class 1	866.3200	2022-09-20
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	Microbiology	Class 2	866.3220	2012-12-17

Official Correspondent

Clement Bordier

US Agent Details

Gerrit Mueller Business: Clear Path Diagnostics Email: gmueller@cpdiag.com Phone: (916) 6447505

Related Public Records

Same Entity

Bordier Affinity Products

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003718445. Last updated year: 2026. Please use registration number 3003718445 when referencing this establishment in official correspondence.