QuickVue 20197
by Quidel Corp.
QuickVue 20197 is a Class II device made by Quidel Corp., listed in FDA GUDID since 23 Apr 2019 (UDI-DI 30014613201977), 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 | Number30014613201977 | Date23 Apr 2019 | StatusListed |
Official records
- AccessGUDID record 30014613201977
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- QuickVue
- Generic name
- Faecal occult blood IVD, control
- Model / Ref / Catalog
- 20197
- Primary DI / UDI-DI
- 30014613201977
- FDA product code
- KHE
- GMDN term
- Faecal occult blood IVD, control
- Device class
- Class II
- Regulation number
- 864.6550
- GUDID distribution status
- In Commercial Distribution
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