Identity
- Trade Name
- Sirrus® Gamma-GT LiquiColor® FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
- Device Name
- A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. FDA UDI
- Model / Reference
- S2960-600 FDA UDI
- Description
- A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. FDA UDI
Identifiers
- Catalog Number
- S2960-600 FDA UDI
- Primary DI / UDI-DI
- 00657498001691 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
- 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
No
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
Sirrus® Gamma-GT LiquiColor® by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry.
- ENVOY 500 GGT REAGENT KIT — VITALSCIENTIFIC
- Dimension® Flex® reagent cartridge GGT — Siemens Healthcare Diagnostics · Class I
- Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz — Roche Diagnostics Corp. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209 — Carolina Liquid Chemistries Corp. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- GAMMA-GT SZASZ SL — VITALSCIENTIFIC
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 7e221e2f-c31a-4861-b151-bca982f1ccb5 36 fields · synced Jun 1, 2026