Biological Sterilization Indicator With Indirect Growth Detection
General Hospital · 21 CFR 880.2806
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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
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Most-reported manufacturers
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- True Indicating, LLCJun 18, 2026
K251559 · InstaTRU Instant Biological Indicator for Steam (IBI-05)
- Steritec ProductsApr 22, 2026
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)
- Terragene S.A.Jul 12, 2024
DEN220042 · Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)