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Aspartate aminotransferase (AST/GOT) (Single Reagent)
EUDAMEDClass IVD General (EU MDR)
Ref D-608 002Ref D-608 003
Identity
- Trade Name
- Aspartate aminotransferase (AST/GOT) (Single Reagent) EUDAMED
- Device Name
- Aspartate aminotransferase (AST/GOT) (Single Reagent) EUDAMED
- Model / Reference
- D-608 002 EUDAMEDD-608 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182709358 EUDAMED62230182709426 EUDAMED
- Basic UDI-DI
- B-62230182709358 EUDAMEDB-62230182709426 EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Category: Total aspartate aminotransferase (AST) IVD, reagent
Aspartate aminotransferase (AST/GOT) (Single Reagent) by Kalians Corporation — Class IVD General — IVDD — 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
- AST (SGOT) Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · 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
- Aspartate Aminotransferase (AST) — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- aminotransferase — C.P.M. COMPAGNIA PER LA MEDICINA S.R.L. · 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-62230182709358 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED a789e6f4-8482-4868-8825-555b631e76aa 61 fields · synced Jul 8, 2026
- EUDAMED b8129d38-2e95-4bee-a7ae-f6071b76939f 61 fields · synced May 18, 2026