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Alanine Aminotransferase (ALT/GPT)-(4+1) UV Kinetic Method
EUDAMEDClass IVD General (EU MDR)
Ref D-604 002Ref D-604 003Ref D-604 001
Identity
- Trade Name
- Alanine Aminotransferase (ALT/GPT)-(4+1) UV Kinetic Method EUDAMED
- Device Name
- Alanine Aminotransferase (ALT/GPT)-(4+1) UV Kinetic Method EUDAMED
- Model / Reference
- D-604 002 EUDAMEDD-604 003 EUDAMEDD-604 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182709662 EUDAMED62230182709730 EUDAMED62230182709594 EUDAMED
- Basic UDI-DI
- B-62230182709662 EUDAMEDB-62230182709730 EUDAMEDB-62230182709594 EUDAMED
- EMDN Code
- W01010103 ALANINE 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: Alanine aminotransferase (ALT) IVD, reagent
Alanine Aminotransferase (ALT/GPT)-(4+1) UV Kinetic Method by Kalians Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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- ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Alinity — Abbott · Class I
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-62230182709662 | 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 (3)
- EUDAMED ddeebb92-5b40-4996-9735-38b70aae4cef 61 fields · synced Aug 4, 2026
- EUDAMED 211e6c65-baba-4804-bd2d-d13efd9b0b1a 61 fields · synced May 17, 2026
- EUDAMED 7af10c01-aa8e-446b-8064-1c6a332d8304 61 fields · synced May 18, 2026