Architect
Gamma-Glutamyl Transferase
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 | Abbott Laboratories, United States |
|---|---|
| FDA product code | JPZ |
| Device type | Colorimetric Method, Gamma-Glutamyl Transpeptidase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1360 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-06-06 |
| Record revised | 2018-03-29 (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 | Handling environment temperature up to 29 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7D65-21 | 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 |
| GGT | Randox Laboratories Limited | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K864208 | 1986-11-24 |
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.