PZJ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lynch Syndrome Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1866
- Medical specialty
- Immunology
- FDA definition
- The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Idylla MSI Test (K211181) | Biocartis NV | 2023-02-27 |
| BOND MMR Antibody Panel (K213348) | Leica Biosystems Newcastle, Ltd. | 2023-02-21 |
| OncoMate MSI Dx Analysis System (K200129) | Promega Corporation | 2021-07-26 |
| VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody (DEN170030) | Ventana Medical Systems | 2017-10-27 |
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Every clearance here is in the API, with alerts when new ones post.