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Gamma GT (IFCC)

EUDAMED

Class IVD General (EU MDR)

Ref 4188

by Giesse Diagnostics Srl

Identity

Trade Name: Gamma GT (IFCC) EUDAMED
Device Name: Gamma GT (IFCC) EUDAMED
Model / Reference: 4188 EUDAMED

Identifiers

Primary DI / UDI-DI: 08053172970505 EUDAMED
Basic UDI-DI: B-08053172970505 EUDAMED
EMDN Code: W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Italy 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 (IFCC) by Giesse Diagnostics Srl — 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
GAMMA GT-S Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Giesse Diagnostics Srl
EUDAMED SRN: IT-MF-000039031

Sources (1)

EUDAMED 31256f99-271d-4580-b1d0-c603bae6eba0 61 fields · synced Jun 19, 2026