AST (SGOT) Kit
by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ 11 variants
Ref 30035Model AST (SGOT) Kit 420mL
AST (SGOT) Kit (30035) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category aspartate amino-transferase) made by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇, registered in EUDAMED on 21 Apr 2026 (Basic UDI-DI B-08683555601407), active as of 24 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08683555601407 08683555601407 | Date21 Apr 2026 | StatusActive |
Official records
- EUDAMED public site B-08683555601407
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / reference
- AST (SGOT) Kit 420mL, 30035
- Primary DI / UDI-DI
- 08683555601407
- Basic UDI-DI
- B-08683555601407
- EMDN code
- W01010110 Aspartate amino-transferase
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000040334
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