Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005847079

FEI Number

3005847079

Entity Name

CEZANNE SAS

City/State/Country

NIMES Gard, FR

Establishment Address

280 allee Graham Bell, Parc Scientifique Georges Besse, NIMES Gard 30035, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

B.R.A.H.M.S GmbH (Owner Number: 10025840)

Owner / Operator Contact Address

Neuendorfstrasse 25, Hennigsdorf, DE-BB 16761, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222251

PMA Number

N/A

All Registered Proprietary Names

B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S sFlt-1 KRYPTOR B.R.A.H.M.S PlGF plus KRYPTOR PreClara Ratio (sFlt-1/PlGF) [New system name] B.R.A.H.M.S PlGF / sFlt-1 KRYPTOR test system [Old system name] B.R.A.H.M.S PlGF plus KRYPTOR LIN B.R.A.H.M.S PlGF plus KRYPTOR QC B.R.A.H.M.S PCT sensitive KRYPTOR QC B.R.A.H.M.S sFlt-1 KRYPTOR LIN B.R.A.H.M.S sFlt-1 KRYPTOR QC B.R.A.H.M.S CgA II KRYPTOR QC B.R.A.H.M.S CgA II KRYPTOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2022-12-06
NTM	Antigen, Inflammatory Response Marker, Sepsis	Microbiology	Class 2	866.3210	2022-12-06
PRI	Procalcitonin Assay	Microbiology	Class 2	866.3215	2022-12-06
QWH	Prognostic Test For Development Or Progression Of Preeclampsia	Clinical Chemistry	Class 2	862.1602	2023-05-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-02-23
QXS	Chromogranin A	Immunology	Class 2	866.6010	2023-09-20

Official Correspondent

No official correspondent registered.

US Agent Details

Jonathan Abed Email: jonathan.abed@thermofisher.com Phone: (541) 5884918

Related Public Records

Same Entity

B.R.A.H.M.S GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number	Establishment Name	Location
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US
3003561301	B.R.A.H.M.S GmbH	HENNIGSDORF Brandenburg, DE
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
2029372	Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, US
3002809144	ABBOTT GmbH	Wiesbaden Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005847079. Last updated year: 2026. Please use registration number 3005847079 when referencing this establishment in official correspondence.