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AST (SGOT) Kit
EUDAMEDClass IVD General (EU MDR)
Ref B29036Model AST (SGOT) Kit 105mLModel AST (SGOT) Kit 225mL
Identity
- Trade Name
- AST (SGOT) Kit EUDAMED
- Device Name
- AST (SGOT) Kit EUDAMED
- Model / Reference
- AST (SGOT) Kit 105mL EUDAMEDB29036 EUDAMEDAST (SGOT) Kit 225mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555614827 EUDAMED08683555614834 EUDAMED
- Basic UDI-DI
- B-08683555614827 EUDAMEDB-08683555614834 EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Category: Total aspartate aminotransferase (AST) IVD, reagent
AST (SGOT) Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Total aspartate aminotransferase (AST) IVD, reagent.
- GOT (AST) — Cypress Diagnostics · IVD General
- ASPARTATE AMINOTRANSFERASE REAGENT KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
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- Aspartate Aminotransferase Kit( IFCC Method) — Coei Biotech Co.Ltd. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- aminotransferase — C.P.M. COMPAGNIA PER LA MEDICINA S.R.L. · IVD General
- Calcium Assay Kit (Arsenazo III Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- AST/GOT — GIESSE DIAGNOSTICS SRL · IVD General
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-08683555614827 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (2)
- EUDAMED d5c2f452-4cd0-4842-a4cc-25ec1b0badcf 61 fields · synced Oct 7, 2026
- EUDAMED 194e9144-7803-42ff-8334-c3e1d247e7ec 61 fields · synced May 17, 2026