PremierPro 6915
PremierPro 6915 is a Class II device made by Prestige Ameritech, listed in FDA GUDID since 1 Aug 2016 (UDI-DI 00818566016409), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00818566016409 | Date1 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00818566016409
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- PremierPro
- Generic name
- Faecal occult blood IVD, kit, rapid colorimetric, clinical
- Model / reference
- 6915
- Primary DI / UDI-DI
- 00818566016409
- FDA product code
- KHE
- GMDN term
- Faecal occult blood IVD, kit, rapid colorimetric, clinical
- Device class
- Class II
- Regulation number
- 864.6550
- GUDID distribution status
- In Commercial Distribution
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