← Back to catalogue
ClearChem Diagnostics Inc. Gamma-glutamyltransferase (GGT)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ClearChem Diagnostics Inc. Gamma-glutamyltransferase (GGT) FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, reagent FDA UDI
- Device Name
- In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL FDA UDI
- Model / Reference
- GGT1130 FDA UDI
- Description
- In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL FDA UDI
Identifiers
- Catalog Number
- GGT1130 FDA UDI
- Primary DI / UDI-DI
- 00852169008133 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 225 Milliliter FDA UDI
Category: Gamma-glutamyltransferase (GGT) IVD, reagent
ClearChem Diagnostics Inc. Gamma-glutamyltransferase (GGT) by Clearchem Diagnostics Inc. — Class I — FDA UDI — listed in FDA GUDID
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clearchem Diagnostics Inc.
Sources (1)
- FDA UDI 12dda5b0-0086-47c6-ab51-50de52e1d02d 37 fields · synced May 30, 2026