MassTrak™
Waters® MassTrak™ Immunosuppressants Kit
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Yunze Biotechnology Co., Ltd. | Minhang Disctrict | Shanghai | Manufacturer | 1 |
Record
| Listed by | Waters Corporation, United States |
|---|---|
| FDA product code | MLM |
| Device type | Enzyme Immunoassay, Tracrolimus |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1678 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K063868 |
| Record published | 2016-09-24 |
| Record revised | 2021-06-04 (version 5) |
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 up to -20 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 186002891 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland Diagnostics | 2 |
| Elecsys Tacrolimus | Roche Diagnostics Gmbh | 2 |
| Alinity | Abbott Ireland Diagnostics | 2 |
| Dimension® Flex® reagent cartridge TAC | Siemens Healthcare Diagnostics Inc | 1 |
| Syva® Emit® 2000 Tacrolimus Assay | Siemens Healthcare Diagnostics Inc | 1 |
| QMS Tacrolimus Immunoassay | Microgenics Corporation | 1 |
| Alinity-Architect | Abbott Laboratories | 1 |
| Atellica CH Tacr | Siemens Healthcare Diagnostics Inc | 1 |
| Dimension® Flex® reagent cartridge Tacr | Siemens Healthcare Diagnostics Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063868 | 2007-05-25 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P970007 | 2002-09-05 | IMX TACROLIMUS II | Abbott Laboratories |
| P970025 | 1999-04-27 | PRO-TRAC II TACROLIMUS ELISA KIT | Diasorin Inc. |
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.