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B·R·A·H·M·S CgA II KRYPTOR QC
EUDAMEDFDA UDIFDA 510(k)Class C (EU MDR)
Ref 083992N
Identity
- Trade Name
- B·R·A·H·M·S CgA II KRYPTOR QC EUDAMEDB.R.A.H.M.S CgA II KRYPTOR QC FDA UDI
- Generic Name
- Chromogranin A IVD, control FDA UDI
- Device Name
- B·R·A·H·M·S CgA II KRYPTOR QC EUDAMED
- Model / Reference
- 083992N EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260157632295 EUDAMEDFDA UDI
- Basic UDI-DI
- 426015763839BCgAIIKQCXXYE EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152005 TUMOUR MARKER CONTROLS EUDAMED
- GMDN Term
- Chromogranin A IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
B·R·A·H·M·S CgA II KRYPTOR QC by B.R.A.H.M.S GmbH — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222251 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 426015763839BCgAIIKQCXXYE | Class C | Active |
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Manufacturer
- Manufacturer
- B·R·A·H·M·S GmbH
- EUDAMED SRN
- DE-MF-000026030
Sources (3)
- EUDAMED 241fee5f-c4e8-47cd-9d3a-ccde62be5deb 61 fields · synced Jun 19, 2026
- FDA UDI f6125b3a-a3dd-4909-93b9-c546cb6024ff 32 fields · synced May 29, 2026
- FDA 510(k) K222251 1 fields · synced May 18, 2026