FDA Registration
Active
🇫🇷 France
Bio-Rad Service France SAS
Reg #: 3035708936
·
FEI: 3035708936
·
Expires 2026
Products
17
Proprietary Names
22
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- Bio-Rad Service France SAS
- Registration Number
- 3035708936
- FEI Number
- 3035708936
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rue des Freres Lumiere
- City
- Mitry Mory Ile-de-France
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K090847
- PMA Number
- BP140120
Owner / Operator
- Firm Name
- Bio-Rad Laboratories (Bio-Rad Services France)
- Operator Number
- 10078397
- Address
- Rue Gustave Eiffel
- City
- MITRY-MORY
- State
- Ile-de-France
- Postal Code
- 77290
- Country
- FR
- Correspondent
- Lucie Watremetz
US Agent
- Business Name
- BIO-RAD LABORATORIES
- Contact Name
- David Bhend
- Address
- 14620 Ne North Woodinville Way
- City
- Woodinville
- State
- WA
- ZIP
- 98072
- Country
- US
- [email protected]
- Phone
- 425 2730193
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2024-01-17 |
| Staphylococcus Aureus Protein A Insoluble | LHJ | Class 1 | Microbiology | No | 2025-01-14 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2025-01-14 |
| Culture Media, Selective And Differential | JSI | Class 1 | Microbiology | No | 2025-01-14 |
| Regulator, Temperature | JRR | Class 1 | Clinical Chemistry | No | 2025-01-14 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2025-01-14 |
| Antigen, Galactomannan, Aspergillus Spp. | NOM | Class 1 | Microbiology | No | 2025-01-14 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2025-01-30 |
| Culture Media, Non-Selective And Differential | JSH | Class 1 | Microbiology | No | 2025-01-14 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2025-01-14 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2025-01-14 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-01-14 |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | Class 2 | Microbiology | No | 2025-01-14 |
| Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | JSO | Class 2 | Microbiology | No | 2025-01-14 |
| Antiserum, Positive Control, Aspergillus Spp. | KFG | Class 1 | Microbiology | No | 2025-01-14 |
| Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test | QSU | Class 2 | Microbiology | No | 2025-01-14 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2025-01-14 |
Proprietary Names
EVOLIS Microplate System
PASTOREX STAPH PLUS
PR4100
SA Select
IPS Microplate incubator
PLATELIA TOXO IgM
PLATELIA ASPERGILUS Ag (with peds and BAL claim)
Platelia SARS COV 2 Total Ab
UriSelect 4
CandiSelect
Geenius reader
Hemoglobin Capillary Collection System
MONOLISA Anti-HAV EIA (manual)
VRE Select (stool claim)
Platelia Aspergillus IgG Negative and Positive Controls
Geenius HIV-1/2 Controls
Geenius HIV-1/2 Supplemental Assay
MONOLISA Anti-HAV IgM EIA (EVOLIS)
Magellan for PR4100
MONOLISA Anti-HAV IgM EIA (manual)
MRSA SELECT II
MONOLISA Anti-HAV EIA (EVOLIS)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device