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Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) is used for the quantitative determination of gamma-GT in human serum. FDA UDI
- Model / Reference
- G571-150 FDA UDI
- Description
- Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) is used for the quantitative determination of gamma-GT in human serum. FDA UDI
Identifiers
- Catalog Number
- G571-150 FDA UDI
- Primary DI / UDI-DI
- 10673486001839 FDA UDI
- 510(k) Number
- K881626 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
Yes
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
Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) by Teco Diagnostics — 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
Cleared under the same submission
K881626 also covers:
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
- Teco Diagnostics
Sources (1)
- FDA UDI 41d07f19-7f6c-4edb-9a43-2b504f9ad2d7 37 fields · synced May 30, 2026