Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003561301

FEI Number

3003561301

Entity Name

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

City/State/Country

HENNIGSDORF Brandenburg, DE

Establishment Address

NEUENDORFSTRASSE 25, HENNIGSDORF Brandenburg 16761, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Thermo Fisher Scientific (Owner Number: 9051947)

Owner / Operator Contact Address

168 3rd Ave, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222251

PMA Number

N/A

All Registered Proprietary Names

Alinity c Gentamicin Reagent Kit B.R.A.H.M.S PlGF plus KRYPTOR B.R.A.H.M.S sFlt-1 KRYPTOR PreClara Ratio (sFlt-1/PlGF) [New system name]. B.R.A.H.M.S PlGF / sFlt-1 KRYPTOR test system [Old system name] Alinity c Vancomycin Reagent Kit Alinity c Digoxin Reagent Kit B.R.A.H.M.S PCT sensitive KRYPTOR Alinity c Theophylline Reagent Kit Alinity c Phenobarbital Reagent Kit Alinity c Tobramycin Reagent Kit B.R.A.H.M.S CgA II KRYPTOR CAL B.R.A.H.M.S PlGF plus KRYPTOR CAL B.R.A.H.M.S sFlt-1 KRYPTOR CAL B.R.A.H.M.S PCT sensitive KRYPTOR CAL Alinity c Amikacin Reagent Kit B.R.A.H.M.S sFlt-1 KRYPTOR QC B.R.A.H.M.S PlGF plus KRYPTOR QC B.R.A.H.M.S CgA II KRYPTOR QC B.R.A.H.M.S PCT sensitive KRYPTOR QC B.R.A.H.M.S PlGF plus KRYPTOR LIN B.R.A.H.M.S sFlt-1 KRYPTOR LIN B.R.A.H.M.S CgA II KRYPTOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2019-04-24
QWH	Prognostic Test For Development Or Progression Of Preeclampsia	Clinical Chemistry	Class 2	862.1602	2023-05-19
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2019-04-24
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-04-24
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2019-04-24
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2022-12-06
PRI	Procalcitonin Assay	Microbiology	Class 2	866.3215	2022-12-06
NTM	Antigen, Inflammatory Response Marker, Sepsis	Microbiology	Class 2	866.3210	2022-12-06
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2019-04-24
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2019-04-24
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2019-04-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-02-23
KLQ	Radioimmunoassay, Amikacin	Clinical Toxicology	Class 2	862.3035	2019-04-24
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

Thermo Fisher Scientific

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010455511	Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd	Suzhou Jiangsu, CN
3006190736	LABOMEX MBP	TIJUANA Baja California, MX
2517925	FISHER SCIENTIFIC COMPANY L.L.C.	PITTSBURGH, PA, US
3006440892	OXOID AUSTRALIA PTY LIMITED	THEBARTON South Australia, AU
1314344	Nalge Nunc International Corporation	Rochester, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K060586	Roche Diagnostics Corp.	ENZYME IMMUNOASSAY, VANCOMYCIN	2006-05-11
K780731	Vitek Systems, Inc.	LIDOCAINE CALIBRATOR KIT	1979-01-17
K833380	E.I. Dupont DE Nemours & Co., Inc.	LIDOAINE CALIBRATOR	1983-12-27
K851032	Roche Diagnostic Systems, Inc.	COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C	1985-04-03
K914151	Instrumentation Laboratory CO	IL TEST(TM DIGOXIN	1991-11-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2008	Thermo Fisher Scientific	1	Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Z-0042-2020	Roche Diagnostics Operations, Inc.	2	Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Z-0043-2020	Roche Diagnostics Operations, Inc.	2	Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Z-0030-2013	Siemens Healthcare Diagnostics, Inc.	2	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

Similar Registrations

Registration Number	Establishment Name	Location
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
3002806944	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	LLANBERIS Wales, GB
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG
8020888	Siemens Healthcare Diagnostics Manufacturing Ltd.	SWORDS Dublin, IE
3012963943	Ortho Clinical Diagnostics, K.K.	Shinagawa-ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003561301. Last updated year: 2026. Please use registration number 3003561301 when referencing this establishment in official correspondence.