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Ɣ- Glutamyl transferase (GGT) (4+1)
EUDAMEDClass IVD General (EU MDR)
Ref D-621 003Ref D-621 001
Identity
- Trade Name
- Ɣ- Glutamyl transferase (GGT) (4+1) EUDAMED
- Device Name
- Ɣ- Glutamyl transferase (GGT) (4+1) EUDAMED
- Model / Reference
- D-621 003 EUDAMEDD-621 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182708504 EUDAMED62230182708368 EUDAMED
- Basic UDI-DI
- B-62230182708504 EUDAMEDB-62230182708368 EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE 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
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: Gamma-glutamyltransferase (GGT) IVD, reagent
Ɣ- Glutamyl transferase (GGT) (4+1) by Kalians Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, reagent.
- Gamma-GT (IFCC) — Thermo Fisher Scientific Oy · Class B
- Gamma-Glutamyl Transferase Reagent — Beckman Coulter, Inc. · IVD General
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- Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand) — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
- Alinity — ABBOTT IRELAND · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- GAMMA GT-S Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- γ-Glutamyl Transferase Assay Kit (Rate Assay) — Da Te Bioengineering Technology Co., LTD. · 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-62230182708504 | 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 6469880c-7e8a-4822-ac09-a6abc3aae309 61 fields · synced Jul 9, 2026
- EUDAMED d5778981-a1bd-4cc9-b01d-d49f0b894e21 61 fields · synced May 17, 2026