Data / Medical devices / Germany / B.R.A.H.M.S GmbH
B.R.A.H.M.S GmbH: FDA-registered device maker in HENNIGSDORF Brandenburg, Germany, 12 510(k) clearances
B.R.A.H.M.S GmbH is registered with the FDA (registration 3003561301) in HENNIGSDORF Brandenburg, Germany. It lists 19 device types. The FDA files 12 510(k) clearances under its listings, the newest dated September 18, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003561301
- Address
- Neuendorfstrasse 25, HENNIGSDORF Brandenburg, Germany, 16761
- Owner or operator
- Thermo Fisher Scientific (9051947)
- Roles
- Specification developer
- First device listed
- April 24, 2019
- Registered through
- 2026
- Brand names listed
- Alinity c Amikacin Reagent Kit, Alinity c Digoxin Reagent Kit, Alinity c Gentamicin Reagent Kit, Alinity c Phenobarbital Reagent Kit, Alinity c Phenytoin Reagent Kit, Alinity c Theophylline Reagent Kit, Alinity c Tobramycin Reagent Kit, Alinity c Valproic Acid Reagent Kit and more
Devices it lists
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 |
| May 18, 2023 | DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | QWH | Unknown | Brahms GmbH, Part of Thermo Fisher Scientific | accessdata.fda.gov |
| May 31, 2017 | K171338 | B R A H M S PCT sensitive KRYPTOR | PRI | Substantially Equivalent | Brahms GmbH | accessdata.fda.gov |
| April 26, 2013 | K123271 | ABBOTT PHENOBARBITAL ASSAY | DLZ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| July 21, 2006 | K060998 | QMS TOBRAMYCIN | LCR | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| June 15, 2006 | K060709 | MULTIGENT GENTAMICIN | LCD | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| November 1, 2005 | K052815 | QMS AMIKACIN REAGENTS | KLQ | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| April 1, 2005 | K050419 | QMS VANCOMYCIN | LEH | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| April 28, 2003 | K030405 | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 | LEG | Substantially Equivalent | Seradyn | accessdata.fda.gov |
| October 24, 2002 | K023058 | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM | KXT | Substantially Equivalent | Seradyn | accessdata.fda.gov |
| June 27, 1996 | K961462 | CEDIA THEOPHYLLINE ASSAY | KLS | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| January 21, 1993 | K923783 | ETHYL ALCOHOL ASSAY | DMT | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 12, 2026 | 98561 | Class II | Ongoing | BRAHMS KRYPTOR compact REACT, REF: 89986, used with BRAHMS PlGF Plus KRYPTOR, REF: 859075N, and run on the BRAHMS KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor | Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio res | accessdata.fda.gov |
Compare with other makers
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Updated April 8, 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.