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Aspartate Aminotransferase (AST)
EUDAMEDClass IVD General (EU MDR)
Ref B22035Model Aspartate Aminotransferase (AST) 180 mLRef B21035Model Aspartate Aminotransferase (AST) 426 mL
Identity
- Trade Name
- Aspartate Aminotransferase (AST) EUDAMED
- Device Name
- Aspartate Aminotransferase (AST) EUDAMED
- Model / Reference
- Aspartate Aminotransferase (AST) 180 mL EUDAMEDB22035 EUDAMEDAspartate Aminotransferase (AST) 426 mL EUDAMEDB21035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555611901 EUDAMED08683555610157 EUDAMED
- Basic UDI-DI
- B-08683555611901 EUDAMEDB-08683555610157 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
Aspartate Aminotransferase (AST) by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — IVDD — listed in EUDAMED
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
- GOT LIQUID R1:4x40, R2:2x20 ml (ΗΙΤ) — Biotechnological Applications Ltd · IVD General
- 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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08683555611901 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (2)
- EUDAMED e5250011-4208-40dc-823f-2a3042c2ef1d 61 fields · synced Jul 14, 2026
- EUDAMED 450e3ee6-1b58-4093-848c-8bd40684fe0a 61 fields · synced May 17, 2026