QuickVue 20152
by Quidel Corp.
QuickVue 20152 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K011097 on 8 May 2001 and listed in FDA GUDID since 7 Mar 2019 (UDI-DI 30014613201526), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30014613201526 | Date7 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011097 | Date8 May 2001 | StatusActive |
Official records
- AccessGUDID record 30014613201526
- FDA 510(k) database K011097
Across registries
- FDA 510(k) K011097 decided 8 May 2001 Active
- FDA GUDID UDI-DI 30014613201526 listed 7 Mar 2019 Listed
Recalls
-
- Ongoing Z-2169-2026
Product has the potential for false positive results
-
- Ongoing Z-2545-2025
Dipstick strep A test has potential for false positive results.
Timeline
- Cleared FDA 510(k) K011097
- Listed FDA GUDID 30014613201526
- Recall initiated FDA recalls Z-2545-2025
- Recall initiated FDA recalls Z-2169-2026
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- Withdrawn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, kit, rapid ICT, clinical
- Model / Ref / Catalog
- 20152
- Primary DI / UDI-DI
- 30014613201526
- 510(k) Number
- FDA product code
- GTY
- GMDN term
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
- Device class
- Class I
- Regulation number
- 866.3740
- GUDID distribution status
- In Commercial Distribution