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GAMMA GT-S Kit
EUDAMEDClass IVD General (EU MDR)
Ref B24160Model GAMMA GT-S Kit 170mL Ref B34161Model GAMMA GT-S Kit 244mLRef B45161Model GAMMA GT-S Kit Ref B29161Model GAMMA GT-S Kit 105mLRef B33161Model GAMMA GT-S Kit 210mLRef B33160Model GAMMA GT-S Kit 420mLRef B30160Ref B30161Ref B28160Model GAMMA GT-S Kit 312mL
Identity
- Trade Name
- GAMMA GT-S Kit EUDAMED
- Device Name
- GAMMA GT-S Kit EUDAMED
- Model / Reference
- GAMMA GT-S Kit 170mL EUDAMEDB24160 EUDAMEDGAMMA GT-S Kit 244mL EUDAMEDB34161 EUDAMEDGAMMA GT-S Kit EUDAMEDB45161 EUDAMEDGAMMA GT-S Kit 105mL EUDAMEDB29161 EUDAMEDGAMMA GT-S Kit 210mL EUDAMEDB33161 EUDAMEDGAMMA GT-S Kit 420mL EUDAMEDB33160 EUDAMEDB30160 EUDAMEDB30161 EUDAMEDGAMMA GT-S Kit 312mL EUDAMEDB28160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555613592 EUDAMED08683555616654 EUDAMED08683555622433 EUDAMED08683555600158 EUDAMED08683555615862 EUDAMED08683555615855 EUDAMED08683555614278 EUDAMED08683555614285 EUDAMED08683555618870 EUDAMED
- Basic UDI-DI
- B-08683555613592 EUDAMEDB-08683555616654 EUDAMEDB-08683555622433 EUDAMEDB-08683555600158 EUDAMEDB-08683555615862 EUDAMEDB-08683555615855 EUDAMEDB-08683555614278 EUDAMEDB-08683555614285 EUDAMEDB-08683555618870 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 Kit 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-08683555613592 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (9)
- EUDAMED 87096d74-ed99-4f09-9384-4146241e7f73 61 fields · synced Jul 27, 2026
- EUDAMED d01fab19-3e86-48f2-b531-5d2bc6ae64a4 61 fields · synced May 17, 2026
- EUDAMED cb130d2d-9fed-4204-a695-4b8b2ba96c2a 61 fields · synced May 17, 2026
- EUDAMED 88216262-0b4b-4d08-a2fd-3be5a7ca4ac4 61 fields · synced May 17, 2026
- EUDAMED 3ccc4027-c4f9-4cf1-85a1-5b09f0a4582d 61 fields · synced May 17, 2026
- EUDAMED 246bc2bb-c3ef-4907-a3ca-c5d3ec3e7d74 61 fields · synced May 18, 2026
- EUDAMED 82faf754-36db-43bd-a147-c3687b422c82 61 fields · synced May 18, 2026
- EUDAMED c80100d3-0e6f-4794-b126-d2222c374664 61 fields · synced May 18, 2026
- EUDAMED c03da1bc-d627-45f8-aafc-c3f3d65e5e4f 61 fields · synced May 19, 2026