Data / Medical devices / France / Cezanne SAS
Cezanne SAS: FDA-registered device maker in NIMES Gard, France, 1 510(k) clearance
Cezanne SAS is registered with the FDA (registration 3005847079) in NIMES Gard, France. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 18, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005847079
- Address
- 280 allee Graham Bell Parc Scientifique Georges Besse, NIMES Gard, France, 30035
- Owner or operator
- B.R.A.H.M.S GmbH (10025840)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 6, 2022
- Registered through
- 2026
- Brand names listed
- B.R.A.H.M.S CgA II KRYPTOR, B.R.A.H.M.S CgA II KRYPTOR CAL, B.R.A.H.M.S CgA II KRYPTOR QC, B.R.A.H.M.S KRYPTOR BUFFER, B.R.A.H.M.S KRYPTOR compact DILCUP, B.R.A.H.M.S KRYPTOR compact PLUS, B.R.A.H.M.S KRYPTOR compact REACT, B.R.A.H.M.S KRYPTOR compact SOLUTION 1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, Inflammatory Response Marker, Sepsis | NTM | 2 | Contract manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Contract manufacturer | accessdata.fda.gov |
| Chromogranin A | QXS | 2 | Manufacturer | accessdata.fda.gov |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | 2 | Contract manufacturer | accessdata.fda.gov |
| Fluorometer | JZT | 1 | Contract manufacturer | accessdata.fda.gov |
| Procalcitonin Assay | PRI | 2 | Contract manufacturer | accessdata.fda.gov |
| Prognostic Test For Development Or Progression Of Preeclampsia | QWH | 2 | Contract manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| September 18, 2023 | K222251 | B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC | QXS | Substantially Equivalent | B.R.A.H.M.S GmbH, Part of Thermo Fisher | accessdata.fda.gov |
Compare with other makers
- All makers of Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- All makers of Antigen, Inflammatory Response Marker, Sepsis
- All makers of Procalcitonin Assay
- All makers of Prognostic Test For Development Or Progression Of Preeclampsia
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Chromogranin A
Updated September 18, 2023. 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.