Identity
- Trade Name
- GGT FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
- Device Name
- A GGT test system is a device intended for the quantitative in vitro determination of L Gamma Glutamyltransferase (GGT) activity in serum and plasma. This product is suitable for use on RX series instruments which includes the RX daytona and the RX imola. FDA UDI
- Model / Reference
- GT3817 FDA UDI
- Description
- A GGT test system is a device intended for the quantitative in vitro determination of L Gamma Glutamyltransferase (GGT) activity in serum and plasma. This product is suitable for use on RX series instruments which includes the RX daytona and the RX imola. FDA UDI
Identifiers
- Catalog Number
- GT3817 FDA UDI
- Primary DI / UDI-DI
- 05055273203455 FDA UDI
- FDA Product Code
- JPZ 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
- 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
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
Yes
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, kit, spectrophotometry
Ggt by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
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- gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz — Roche Diagnostics Corp. · Class I
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 8f64486b-2322-45dd-b7f9-5cd21eeca494 36 fields · synced May 30, 2026