Identity
- Trade Name
- Pointe Scientific, Inc. GGT FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Gamma glutamyl transferase Reagent is for the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Hitachi analyzers. For in vitro diagnostic use only. 1 x 1L, 1 x 400ml FDA UDI
- Model / Reference
- HG959-1400 FDA UDI
- Description
- Gamma glutamyl transferase Reagent is for the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Hitachi analyzers. For in vitro diagnostic use only. 1 x 1L, 1 x 400ml FDA UDI
Identifiers
- Catalog Number
- HG959-1400 FDA UDI
- Primary DI / UDI-DI
- 00811727014740 FDA UDI
- FDA Product Code
- JQB FDA UDI
- GMDN Term
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1360 FDA UDI
- Commercial Distribution
- Not 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
Pointe Scientific, Inc. GGT by Medtest DX — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtest DX
Sources (1)
- FDA UDI e9145899-e96b-45d6-8041-a00ab32d23f7 37 fields · synced May 29, 2026