GGT
A GGT test system is a device intended for the quantitative in vitro determination of L Gamma Glutamyltransferase (GGT) activity in serum and plasma. This product is suitable for use on RX…
A GGT test system is a device intended for the quantitative in vitro determination of L Gamma Glutamyltransferase (GGT) activity in serum and plasma. This product is suitable for use on RX series instruments which includes the RX daytona and the RX imola.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | JPZ |
| Device type | Colorimetric Method, Gamma-Glutamyl Transpeptidase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-24 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| 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 |
|---|---|---|
| GT3817 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 18 |
| Carolina Liquid Chemistries Corp.® GGT Reagent KIT DT209 | Carolina Liquid Chemistries | 3 |
| Gamma-Glutamyltranserase (GGT) | Randox Laboratories Limited | 3 |
| Synchron | Beckman Coulter, Inc. | 2 |
| Architect | Abbott Ireland | 2 |
| Alinity | Abbott Medical | 2 |
| Alinity | Abbott Ireland | 2 |
| Architect | Abbott Medical | 2 |
| Spotchem™ II GGT | Arkray USA, Inc. | 1 |
| ACE | Alfa Wassermann | 1 |
| Architect | Abbott Laboratories | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K923509 | 1992-12-03 |
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.