Data / Medical devices / France / Immunodiagnostic Systems France SAS
Immunodiagnostic Systems France SAS: FDA-registered device maker in POUILLY EN AUXOIS Cote-d'Or, France, 1 510(k) clearance
Immunodiagnostic Systems France SAS is registered with the FDA (registration 9615777) in POUILLY EN AUXOIS Cote-d'Or, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 15, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615777
- FEI number
- 3007034602
- Address
- 42 Rue Stephane Mazeau, POUILLY EN AUXOIS Cote-d'Or, France, 21320
- Owner or operator
- IMMUNODIAGNOSTIC SYSTEMS LTD. (8021924)
- Roles
- Manufacturer
- First device listed
- December 8, 2016
- Registered through
- 2026
- Brand names listed
- IDS-iSYS 25 VitDS, IDS-iSYS 25 VitDS Control Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Vitamin D | MRG | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| November 15, 2016 | K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Vitamin D
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated November 15, 2016. 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.