Vitros
VITROS Chemistry Products GGT Slides
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | JQB |
| Device type | Kinetic Method, Gamma-Glutamyl Transpeptidase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-18 |
| Record revised | 2023-06-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Can also store at or below -18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8257289 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synermed® | Infrared Laboratory Systems LLC | 6 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 5 |
| JAS Diagnostics | Drew Scientific, Ltd. | 4 |
| Gamma-Glutamyltransferase ver.2 Standardized against Ifcc / Szasz | Roche Diagnostics Gmbh | 4 |
| Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-240 | Teco Diagnostics | 3 |
| GGT Assay | Sekisui Diagnostics, LLC | 2 |
| Pointe Scientific, Inc. GGT | Horiba Instruments Incorporated | 2 |
| AU | Beckman Coulter, Inc. | 2 |
| Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) | Teco Diagnostics | 2 |
| Gamma-GT LiquiColor® | Stanbio Laboratory, L.P. | 2 |
| Pointe Scientific, Inc. GGT R1 | Horiba Instruments Incorporated | 1 |
| Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2) | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 27. All products under Kinetic Method, Gamma-Glutamyl Transpeptidase
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.