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Gamma GT-S (GGT-S)
EUDAMEDClass IVD General (EU MDR)
Ref B21161Model Gamma GT-S 210 mLRef B21160Model Gamma GT-S 426 mL
Identity
- Trade Name
- Gamma GT-S (GGT-S) EUDAMED
- Device Name
- Gamma GT-S EUDAMED
- Model / Reference
- Gamma GT-S 210 mL EUDAMEDB21161 EUDAMEDGamma GT-S 426 mL EUDAMEDB21160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555610515 EUDAMED08683555610508 EUDAMED
- Basic UDI-DI
- B-08683555610515 EUDAMEDB-08683555610508 EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE 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: Gamma-glutamyltransferase (GGT) IVD, reagent
Gamma GT-S (GGT-S) by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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
- γ - Glutamyltransferase (GGT) – Liquizyme (9+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Ɣ- Glutamyl transferase (GGT) (4+1) — Kalians Corporation · IVD General
- 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
- 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-08683555610515 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (2)
- EUDAMED 1dc3d290-7760-4db6-83c9-b6824be797db 61 fields · synced Oct 7, 2026
- EUDAMED d29da240-b4cf-4c84-bc51-ec778fc91ff7 61 fields · synced May 19, 2026