B.R.A.H.M.S GmbH
HENNIGSDORF Brandenburg, DE
B.R.A.H.M.S GmbH appears in FDA device records in HENNIGSDORF Brandenburg, DE. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for B.R.A.H.M.S GmbH between 2016 and 2017. The busiest year on record is 2016, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003561301 | 3003561301 | B.R.A.H.M.S GmbH | NEUENDORFSTRASSE 25, HENNIGSDORF Brandenburg 16761 DE | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NTMAntigen, Inflammatory Response Marker, Sepsis
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- QXSChromogranin A
- PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- KXTEnzyme Immunoassay, Digoxin
- LCDEnzyme Immunoassay, Gentamicin
- DLZEnzyme Immunoassay, Phenobarbital
- KLSEnzyme Immunoassay, Theophylline
- LEGEnzyme Immunoassay, Valproic Acid
- LCRFluorescent Immunoassay, Tobramycin
- JZTFluorometer
- PRIProcalcitonin Assay
- QWHPrognostic Test For Development Or Progression Of Preeclampsia
- KLQRadioimmunoassay, Amikacin
- LEHRadioimmunoassay, Vancomycin
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1795-2026 | B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. 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 results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain