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Bio-Rad

Active in EUDAMED

Country not established EUDAMED SRN FR-MF-000006261

Bio-Rad is a medical device manufacturer, with 544 devices listed in 4 registries (FDA Class I and II; EU Class B and A) as of 14 Nov 2026.

Devices
544
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA 510(k) 319
  • EUDAMED 211
  • FDA GUDID 25
  • FDA PMA 1

A device listed in two registries counts in both.

Device classes
  • FDA Class I 189
  • FDA Class II 153
  • EU Class B 108
  • EU Class A 49
  • EU Class C 27
  • EU IVD Annex II List A 9
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN FR-MF-000006261
  • DUNS 269902602

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Bio-Rad makes

Bio-Rad manufactures in vitro diagnostic (IVD) products including selective and chromogenic agar culture media for bacterial isolation, such as differential and MRSA-specific agar plates. Their portfolio also includes antigen detection kits for *Staphylococcus aureus* and *Aspergillus* species, as well as enzyme immunoassay (EIA) test kits for hepatitis A virus antibodies (IgM and total). Additionally, they produce microplate/tube incubators and EIA analysers for automated diagnostic testing.

Bio-Rad’s devices are regulated under FDA classifications including Class I, Class II, Class III, and non-classified (N) products, with submissions recorded via 510(k) clearances and UDI listings.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue544

Newest first, rows 1-50 of 544

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  • Access HIV combo V2 QC Ref C28432

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Platelia Candida Ag Plus Ref 62784

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Access HCV Ab V3 Calibrators Ref B33459

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Optochin Ref 53852

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Platelia Aspergillus IgG Ref 62783

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • MRSASelect II Ref 63759

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • VRESelect Ref 63752

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Rpr Ref 72516

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • StrepBSelect Ref 63750

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Β Carba Test Ref 68260

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Tpha Ref 72503

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Auxacolor 2 Ref 56513

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Platelia Toxo IgM Ref 72841

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Kovacs Ref 55313

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • Access HCV Ab V3 QC Ref B33460

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Tpha Ref 72504

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Access HIV combo V2 Calibrators Ref C28431

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Platelia Candida Ab Plus Negative & Positive controls Ref 62787

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Platelia Dengue NS1 Ag Ref 72830

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Platelia Rabies II Ref 3551180

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • MRSASelect II Ref 63757

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Access HIV combo V2 Ref C28430

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Access HIV combo V2 QC plus Ref C43576

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Platelia Rubella IgM Ref 72851

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Platelia Rubella IgG Ref 72850

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Geenius HIV 1/2 Confirmatory Assay Ref 72460

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • UriSelect4 Ref 12013236

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Syphilis Total Ab Ref 72530

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Platelia Toxo IgG Avidity Ref 72842

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Platelia Candida Ab Plus Ref 62785

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Access HCV Ab V3 Ref B33458

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Platelia Aspergillus Ag Ref 62794

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Geenius HIV 1/2 Confirmatory Controls Ref 72329

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • UriSelect 4 Ref 64694

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Syphilis Total Ab Ref 72531

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • CLINDAMYCIN 2 µg Ref 66328

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • QUINUPRISTIN-DALFOPRISTIN 15µg Ref 67528

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • CEFAZOLIN 30 µg Ref 66258

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Mueller-Hinton agar + Sheep Blood Ref 63825

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • CIPROFLOXACIN 5 µg Ref 68648

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • VANCOMYCIN 5 µg Ref 67828

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Sven Gard agar Ref 53430

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • AMPICILLIN 10 µg Ref 66128

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Pastorex Strep A Ref 61726

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • STREPTOMYCIN (HIGH LOAD) 300 µg Ref 67608

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • ERTAPENEM 10 µg Ref 67518

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • B.E.A. agar Ref 63994

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • CEFUROXIME 30 µg Ref 66358

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • CEFTIBUTEN 30 µg Ref 67638

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • CEFTAZIDIME 30 µg Ref 66308

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

Rows 1-50 of 544

Showing 1-50 of 544

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000006261
DUNS number
269902602
EU VAT number
FR58789947322
EUDAMED status
Active
EUDAMED registered name
Bio-Rad
Registered address
3, Boulevard Raymond Poincaré, 92430, MARNES LA COQUETTE, France
Phone
1-800-224-6723
PRRC contact
Aïcha Hammadou(public in EUDAMED)

Sites1

  • Bio-Rad FRFEI 3003992026 62 devices

Frequently asked questions

How many devices does Bio-Rad have in the registry?

The registry currently lists 544 devices for Bio-Rad. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bio-Rad's devices?

Among its 50 most recently registered devices, Bio-Rad has devices listed in EUDAMED (50 devices).

What risk classes do Bio-Rad's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Bio-Rad's devices are IVDR Class A, IVDR Class B, IVDR Class C, IVD general and IVD Annex II List A. Each device page shows its own class and authorisation.

What are the newest devices from Bio-Rad in the registry?

The most recently registered devices listed for Bio-Rad include Access HIV combo V2 QC, Platelia Candida Ag Plus, Access HCV Ab V3 Calibrators and Optochin.

Generated automatically from registry data and not verified by a human reviewer.