VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
Device Facts
| Record ID | DEN110006 |
|---|---|
| Device Name | VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR |
| Applicant | STERIS Corporation |
| Product Code | OWP · General Hospital |
| Decision Date | Jul 12, 2013 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 880.2805 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.
