Pointe Scientific, Inc. GGT
Pointe Scientific, Inc. GGT Reagent is for the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Olympus analyzers. For in vitro diagnostic use…
Pointe Scientific, Inc. GGT Reagent is for the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Olympus analyzers. For in vitro diagnostic use only. 5 x 42ml, 5 x 17ml
1manufacturer
2catalogue numbers in this listing
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 | Horiba Instruments Incorporated, United States |
|---|---|
| FDA product code | JQB |
| Device type | Kinetic Method, Gamma-Glutamyl Transpeptidase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1360 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K973157 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OG959-295 | In distribution | |
| HG959-295 | 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 |
| 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 |
| Piccolo General Chemistry 6 | Abaxis, 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.