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Alt (sgpt)
EUDAMEDClass IVD General (EU MDR)
Ref B21015Ref B80019Model Reagent 1:2x100mL ,Reagent 2:2x25mL
by Bioanalytic Diagnostik Kimya Sanayi ve Ticaret Limited Şirketi
Identity
- Trade Name
- ALT (SGPT) EUDAMED
- Device Name
- ALT (SGPT) EUDAMEDAlanina Aminotransferase EUDAMED
- Model / Reference
- B21015 EUDAMEDReagent 1:2x100mL ,Reagent 2:2x25mL EUDAMEDB80019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681554401349 EUDAMEDD-8681554453218AJ EUDAMED
- Basic UDI-DI
- B-08681554401349 EUDAMEDB-8681554453218AJ EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMEDW01029099 IMMUNOCHEMISTRY REAGENTS - OTHER 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: Alanine aminotransferase (ALT) IVD, reagent
Alt (sgpt) by Bioanalytic Diagnostik Kimya Sanayi ve Ticaret Limited Şirketi — 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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- 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-08681554401349 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000034087
Sources (2)
- EUDAMED 4cc6b2c9-e029-4c45-a812-ff14a50b2ded 61 fields · synced Jul 29, 2026
- EUDAMED 274f04d1-35b2-4700-a3d1-af57f0954404 61 fields · synced May 18, 2026