Data / Medical devices / Single (Specified) Analyte Controls (Assayed And Unassayed) / France
FDA-registered makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in France: 6 establishments
6 establishments in France are registered with the FDA to make Single (Specified) Analyte Controls (Assayed And Unassayed) (product code JJX). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Product code
- JJX
- Country
- France
Makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in France
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cezanne SAS | NIMES Gard, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunodiagnostic Systems France SAS | POUILLY EN AUXOIS Cote-d'Or, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunotech SAS, a Beckman Coulter company | MARSEILLE, CEDEX 9 Bouches-du-Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sebia | EVRY Essonne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VitalScientific | SEES Normandie, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.