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HYDRASHIFT 2/4 isatuximab (40 TESTS)
EUDAMEDFDA UDIFDA 510(k)Class A (EU MDR)
Ref 4642510(k) K203184
by sebia
Identity
- Trade Name
- HYDRASHIFT 2/4 isatuximab (40 TESTS) EUDAMEDHydrashift 2 4 isatuximab FDA UDI
- Generic Name
- Multiple clinical chemistry protein IVD, reagent FDA UDI
- Device Name
- HYDRASHIFT 2/4 isatuximab (40 TESTS) EUDAMED
- Model / Reference
- 4642 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 4642 FDA UDI
- Primary DI / UDI-DI
- 03607360046425 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607364642BUEC EUDAMED
- 510(k) Number
- K203184 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
No
FDA UDI
HYDRASHIFT 2/4 isatuximab (40 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
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203184 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 3607364642BUEC | Class A | Active |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (3)
- EUDAMED 0a8c527e-baeb-41db-86f2-8ba0fa0be997 85 fields · synced Jun 18, 2026
- FDA UDI b9575493-fc7d-455c-a4e7-c2aceedd906e 36 fields · synced May 30, 2026
- FDA 510(k) K203184 1 fields · synced May 18, 2026