Data / Medical devices / France / Bio-Rad Service France SAS
Bio-Rad Service France SAS: FDA-registered device maker in Mitry Mory Ile-de-France, France, 9 510(k) clearances
Bio-Rad Service France SAS is registered with the FDA (registration 3035708936) in Mitry Mory Ile-de-France, France. It lists 17 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035708936
- Address
- Rue des Freres Lumiere, Mitry Mory Ile-de-France, France, 77290
- Owner or operator
- Bio-Rad Laboratories (Bio-Rad Services France) (10078397)
- Roles
- Exporter to the US
- First device listed
- January 17, 2024
- Registered through
- 2026
- Brand names listed
- CandiSelect, EVOLIS Microplate System, Geenius HIV-1/2 Controls, Geenius HIV-1/2 Supplemental Assay, Geenius reader, Hemoglobin Capillary Collection System, IPS Microplate incubator, MONOLISA Anti-HAV EIA (EVOLIS) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 28, 2017 | K171061 | MRSASelect II | JSO | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 6, 2012 | K122187 | VRESELECT CULTURE MEDIUM | JSO | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 13, 2011 | K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | NOM | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| October 29, 2009 | K092355 | MONOLISA ANTI-HAV EIA | LOL | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| October 29, 2009 | K092353 | MONOLISA ANTI-HAV IGM EIA | LOL | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| July 1, 2009 | K090847 | PLATELIA TOXO IGM KIT MODEL 26211 | LGD | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| June 3, 2009 | K090737 | HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI | JKA | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 3, 2007 | K063319 | MONOLISA ANTI-HAV IGM EIA | LOL | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| May 3, 2007 | K063318 | MONOLISA ANTI-HAV EIA | LOL | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Assay, Glycosylated Hemoglobin
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Hepatitis A Test (Antibody And Igm Antibody)
Updated December 28, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.