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Panels › General Hospital › Product code QVB · Class 2

Biological Sterilization Indicator With Indirect Growth Detection

Regulation 880.2806

2510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in QVB

Decided510(k)Device and applicantCode
Jun 18, 2026K251559InstaTRU Instant Biological Indicator for Steam (IBI-05)
True Indicating, LLC
QVB
Apr 22, 2026K252306Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300
Steritec Products
QVB
Jul 12, 2024DEN220042Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
Terragene S.A., AR
QVB

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