Cranbury, NJ, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Class II | Microbiology | 1 | 2026-01-15 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Class II | Microbiology | 1 | 2025-06-17 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Class I | Microbiology | 1 | 2024-07-30 |
| QVF | — | — | — | 1 | 2024-01-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-15 | K252283 | Nano-Check Influenza A+B Test | PSZ | Class II | Microbiology |
| 2025-06-17 | K243561 | Nano-Check Influenza+COVID-19 Dual Test | SCA | Class II | Microbiology |
| 2024-07-30 | K240280 | Nano-Check RSV Test | GQG | Class I | Microbiology |
| 2024-01-23 | K231187 | Nano-Check COVID-19 Antigen Test | QVF | — | — |