← Back to catalogue
HYDRASHIFT 2/4 daratumumab (20 TESTS)
EUDAMEDFDA UDIFDA 510(k)Class A (EU MDR)
Ref 4639
by sebia
Identity
- Trade Name
- HYDRASHIFT 2/4 daratumumab (20 TESTS) EUDAMEDHYDRASHIFT 2 4 daratumumab 20 tests FDA UDI
- Generic Name
- Multiple clinical chemistry protein IVD, reagent FDA UDI
- Device Name
- HYDRASHIFT 2/4 daratumumab (20 TESTS) EUDAMED
- Model / Reference
- 4639 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 4639 FDA UDI
- Primary DI / UDI-DI
- 03607360046395 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607364639BUF8 EUDAMED
- 510(k) Number
- K190851 FDA UDI
- FDA Product Code
- CFF FDA UDI
- EMDN Code
- W01029001 ANTISERA (MONOVALENT AND POLYVALENT) EUDAMED
- GMDN Term
- Multiple clinical chemistry protein IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Market of Registration
- France 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
No
EUDAMED
Microbial Substances
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
HYDRASHIFT 2/4 daratumumab (20 TESTS) by Sebia — Class A — 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
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 | K172195 | Class A | Active |
| FDA 510(k) | United States | FDA_510K | K190851 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 3607364639BUF8 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (3)
- EUDAMED e3d9f630-1a1f-4bb2-bd69-f62c6c886501 61 fields · synced Jul 10, 2026
- FDA UDI dae027af-0127-45a9-86b1-363f96a78250 35 fields · synced May 30, 2026
- FDA 510(k) K172195 1 fields · synced Jun 9, 2026