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Ast/Got 4+1 Sl
EUDAMEDFDA 510(k)Class B (EU MDR)
Ref ASSL-0430Model ASSL-0250510(k) K093883
Identity
- Trade Name
- AST/GOT 4+1 SL EUDAMED
- Device Name
- AST/GOT 4+1 SL EUDAMED
- Model / Reference
- ASSL-0250 EUDAMEDASSL-0430 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700816201 EUDAMED
- Basic UDI-DI
- 37017008ASSL00B3 EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Ast/Got 4+1 Sl by Vitalscientific — Class B — FDA_510K, IVDR — listed in EUDAMED, 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 | K093883 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 37017008ASSL00B3 | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
- FDA Applicant
- Seppim S.A.S.
Sources (2)
- EUDAMED b9b5358a-8484-4e3b-a173-caf92c611f13 85 fields · synced Jun 18, 2026
- FDA 510(k) K093883 1 fields · synced May 18, 2026