FDA Product Code
FDA Product Code QVB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2806
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | 2026-06-18 | Traditional | PDF ↗ |
| K252306 | Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) | Steritec Products | 2026-04-22 | Traditional | PDF ↗ |
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | Terragene S.A. | 2024-07-12 | Direct | — |
Product code QVB · Class II · General Hospital. Data: openFDA.