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Aspartate Aminotransferase (AST) Assay Kit (Aspartic Acid Substrate Method)
EUDAMEDClass IVD General (EU MDR)
Ref R1: 2×60 mL, R2: 2×15 mL
Identity
- Device Name
- Aspartate Aminotransferase (AST) Assay Kit (Aspartic Acid Substrate Method) EUDAMED
- Model / Reference
- R1: 2×60 mL, R2: 2×15 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974760129995 EUDAMED
- Basic UDI-DI
- B-06974760129995 EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
This Aspartate Aminotransferase (AST) Assay Kit, with a substrate method and a concentration range of 2×60 mL to 2×15 mL, is designed for the quantitative measurement of AST in human serum or plasma. It is an IVD device that meets regulatory standards for medical devices in various countries.
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-06974760129995 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 55af7885-f308-4833-8c79-6f27932a4189 61 fields · synced Oct 5, 2026
- EUDAMED 55af7885-f308-4833-8c79-6f27932a4189-1 61 fields · synced Jun 10, 2026
- EUDAMED 55af7885-f308-4833-8c79-6f27932a4189-2 61 fields · synced Jun 10, 2026