QVB
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Biological Sterilization Indicator With Indirect Growth Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2806
- Medical specialty
- General Hospital
- FDA definition
- A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| InstaTRU Instant Biological Indicator for Steam (IBI-05) (K251559) | True Indicating, LLC | 2026-06-18 |
| 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) (K252306) | Steritec Products | 2026-04-22 |
| Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) (DEN220042) | Terragene S.A. | 2024-07-12 |
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Every clearance here is in the API, with alerts when new ones post.