FDA Registration
Active
🇩🇪 Germany
B.R.A.H.M.S GmbH
Reg #: 3003561301
·
FEI: 3003561301
·
Expires 2026
Products
19
Proprietary Names
33
Establishment Types
1
Classifications
19
Registration Details
- Registration Name
- B.R.A.H.M.S GmbH
- Registration Number
- 3003561301
- FEI Number
- 3003561301
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NEUENDORFSTRASSE 25
- City
- HENNIGSDORF Brandenburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K060709
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 9051947
- Address
- 168 3rd Ave
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Prognostic Test For Development Or Progression Of Preeclampsia | QWH | Class 2 | Clinical Chemistry | No | 2023-05-19 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2022-12-06 |
| Procalcitonin Assay | PRI | Class 2 | Microbiology | No | 2022-12-06 |
| Antigen, Inflammatory Response Marker, Sepsis | NTM | Class 2 | Microbiology | No | 2022-12-06 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Fluorescent Immunoassay, Tobramycin | LCR | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2023-02-23 |
| Radioimmunoassay, Amikacin | KLQ | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-02-23 |
| Chromogranin A | QXS | Class 2 | Immunology | No | 2023-09-20 |
| Fluorometer | JZT | Class 1 | Immunology | No | 2023-04-05 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2019-04-24 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2019-04-24 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2019-04-24 |
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
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 SOLUTION 1
B.R.A.H.M.S KRYPTOR compact SOLUTION 4
B.R.A.H.M.S KRYPTOR compact SOLUTION 3
B.R.A.H.M.S KRYPTOR compact REACT
B.R.A.H.M.S KRYPTOR compact SOLUTION 2
B.R.A.H.M.S KRYPTOR compact PLUS
Alinity c Valproic Acid Reagent Kit
Alinity c Phenytoin Reagent Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility