Identity
- Trade Name
- GGT Reagent Set FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, reagent FDA UDI
- Device Name
- For the quantitative kinetic determination of gamma glutamyl transferase (GGT) activity in serum. GGT measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis, and primary and secondary tumors. Elevated GGT levels appear earlier and are more pronounced than those of other liver enzymes, in cases of obstructive jaundice and metastatic neoplasms. FDA UDI
- Model / Reference
- R1 x 500mL, R2 x 125mL FDA UDI
- Description
- For the quantitative kinetic determination of gamma glutamyl transferase (GGT) activity in serum. GGT measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis, and primary and secondary tumors. Elevated GGT levels appear earlier and are more pronounced than those of other liver enzymes, in cases of obstructive jaundice and metastatic neoplasms. FDA UDI
Identifiers
- Catalog Number
- 501-410 FDA UDI
- Primary DI / UDI-DI
- 00812137011978 FDA UDI
- FDA Product Code
- JQB FDA UDI
- GMDN Term
- Gamma-glutamyltransferase (GGT) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gamma-glutamyltransferase (GGT) IVD, reagent
GGT Reagent Set by Clinical Diagnostic Solutions, Inc. — Class I — FDA UDI — listed in 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
- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI 135370e7-e5c3-4c72-8bcc-2dce1ce93f69 36 fields · synced May 31, 2026