ENSURE Biological Indicators SCI-BI100
by Scican Ltd
ENSURE Biological Indicators SCI-BI100 is a Class II device made by Scican Ltd, listed in FDA GUDID since 2 Aug 2016 (UDI-DI 17540196000632), registry data as of 12 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number17540196000632 | Date2 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 17540196000632
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- ENSURE Biological Indicators
- Generic name
- Biological sterilization indicator
- Model / Ref / Catalog
- SCI-BI100
- Primary DI / UDI-DI
- 17540196000632
- FDA product code
- FRC
- GMDN term
- Biological sterilization indicator
- Device class
- Class II
- Regulation number
- 880.2800
- GUDID distribution status
- In Commercial Distribution
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