QuickVue 00354
by Quidel Corp.
QuickVue 00354 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K912868 on 7 Aug 1991 and listed in FDA GUDID since 2 Apr 2019 (UDI-DI 30014613003540), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30014613003540 | Date2 Apr 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK912868 | Date7 Aug 1991 | StatusActive |
Official records
- AccessGUDID record 30014613003540
- FDA 510(k) database K912868
Across registries
- FDA 510(k) K912868 decided 7 Aug 1991 Active
- FDA GUDID UDI-DI 30014613003540 listed 2 Apr 2019 Listed
Timeline
- Cleared FDA 510(k) K912868
- Listed FDA GUDID 30014613003540
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuickVue
- Generic name
- Beta-haemolytic Group A Streptococcus antigen IVD, control
- Model / Ref / Catalog
- 00354
- Primary DI / UDI-DI
- 30014613003540
- 510(k) Number
- FDA product code
- GTZ
- GMDN term
- Beta-haemolytic Group A Streptococcus antigen IVD, control
- Device class
- Class I
- Regulation number
- 866.3740
- GUDID distribution status
- In Commercial Distribution
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