← Back to catalogue
Aspartate aminotransferase (AST/GOT) (4+1) UV Kinetic Method
EUDAMEDClass IVD General (EU MDR)
Ref D-607 004Ref D-607 002Ref D-607 003Ref D-607 005
Identity
- Trade Name
- Aspartate aminotransferase (AST/GOT) (4+1) UV Kinetic Method EUDAMED
- Device Name
- Aspartate aminotransferase (AST/GOT) (4+1) UV Kinetic Method EUDAMED
- Model / Reference
- D-607 004 EUDAMEDD-607 002 EUDAMEDD-607 003 EUDAMEDD-607 005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182709044 EUDAMED62230182708818 EUDAMED62230182708986 EUDAMED62230182709112 EUDAMED
- Basic UDI-DI
- B-62230182709044 EUDAMEDB-62230182708818 EUDAMEDB-62230182708986 EUDAMEDB-62230182709112 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) (4+1) UV Kinetic Method by Kalians Corporation — 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
- 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-62230182709044 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 2242f7fa-1c18-429a-820b-397c3d179c90 61 fields · synced Jul 22, 2026
- EUDAMED f249bf31-6b1a-4623-a658-d59f2c6b4619 61 fields · synced May 17, 2026
- EUDAMED 9771fcd5-6365-42b9-b931-f41b6d751f34 61 fields · synced May 18, 2026
- EUDAMED dee28c4e-f864-4ede-88cc-61c4b4e15bd5 61 fields · synced May 19, 2026