Gamma-Glutamyl Transferase Reagent
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- Gamma-Glutamyl Transferase Reagent EUDAMEDSynchron FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Gamma-Glutamyl Transferase Reagent EUDAMEDGamma-Glutamyl Transferase Reagent (γ-GT 2 x 200) FDA UDI
- Model / Reference
- 442650 EUDAMEDFDA UDI
- Description
- Gamma-Glutamyl Transferase Reagent (γ-GT 2 x 200) FDA UDI
Identifiers
- Catalog Number
- 442650 FDA UDI
- Primary DI / UDI-DI
- D-442650PJ EUDAMED15099590233044 FDA UDI
- Basic UDI-DI
- B-442650PJ EUDAMED
- FDA Product Code
- JPZ FDA UDI
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
- GMDN Term
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1360 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Gamma-glutamyltransferase (GGT) IVD, reagent
Gamma-Glutamyl Transferase Reagent by Beckman Coulter, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, reagent.
- Gamma-GT (IFCC) — Thermo Fisher Scientific Oy · Class B
- 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
- γ-Glutamyl Transferase Assay Kit (Rate Assay) — Da Te Bioengineering Technology Co., LTD. · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-442650PJ | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (2)
- EUDAMED d700fe02-0a43-44af-b86d-bcfabfe9300f 61 fields · synced Jun 8, 2026
- FDA UDI 4ccdee6a-41a2-4565-9c7a-1af81b95a716 34 fields · synced May 30, 2026