GGT Reagent Set
For the quantitative kinetic determination of gamma glutamyl transferase (GGT) activity in serum. GGT measurements are used in the diagnosis and treatment of liver diseases such as…
For the quantitative kinetic determination of gamma glutamyl transferase (GGT) activity in serum. GGT measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis, and primary and secondary tumors. Elevated GGT levels appear earlier and are more pronounced than those of other liver enzymes, in cases of obstructive jaundice and metastatic neoplasms.
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 | Clinical Diagnostic Solutions, 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, Repacker / relabeller, Manufacturer |
| Record published | 2016-10-12 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R1 x 500mL, R2 x 125mL | 2 | 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.