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gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 3002721122 FDA UDI
Identifiers
- Catalog Number
- 3002721122 FDA UDI
- Primary DI / UDI-DI
- 04015630916511 FDA UDI
- 510(k) Number
- K972250 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
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, kit, spectrophotometry
gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry.
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- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- GAMMA-GT SZASZ SL — VITALSCIENTIFIC
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- CLC GAMMA-GLUTAMYL TRANSFERASE GGT REAGENT KIT AU-209 — Carolina Liquid Chemistries Corp. · Class II
Cleared under the same submission
K972250 also covers:
- Ammonia — Roche Diagnostics Corp.
- Ammonia — Roche Diagnostics Corp.
- Ammonia — Roche Diagnostics Corp.
- Amylase EPS ver2 — Roche Diagnostics Corp.
- Lipase colorimetric assay — Roche Diagnostics Corp.
- Lysergic Acid Diethylamide — Roche Diagnostics Corp.
- ONLINE DAT Lysergic Acid Diethylamide — Roche Diagnostics Corp.
- UREABUN — Roche Diagnostics Corp.
- Urea/Bun — Roche Diagnostics Corp.
- UreaBUN — Roche Diagnostics Corp.
- UreaBUN — Roche Diagnostics Corp.
- a-Amylase EPS Pancreatic — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 35f4e530-57a1-4843-8a5f-f22a8323dfdb 34 fields · synced May 30, 2026