QuickVue 20112
by Quidel Corp.
QuickVue 20112 is a Class II device made by Quidel Corp., cleared under FDA 510(k) K102175 on 25 Aug 2010 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613201120), 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 | Number30014613201120 | Date10 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102175 | Date25 Aug 2010 | StatusActive |
Official records
- AccessGUDID record 30014613201120
- FDA 510(k) database K102175
Across registries
- FDA 510(k) K102175 decided 25 Aug 2010 Active
- FDA GUDID UDI-DI 30014613201120 listed 10 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K102175
- Listed FDA GUDID 30014613201120
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuickVue
- Generic name
- Human chorionic gonadotropin beta-subunit IVD, antibody
- Model / Ref / Catalog
- 20112
- Primary DI / UDI-DI
- 30014613201120
- 510(k) Number
- FDA product code
- JHI
- GMDN term
- Human chorionic gonadotropin beta-subunit IVD, antibody
- Device class
- Class II
- Regulation number
- 862.1155
- GUDID distribution status
- In Commercial Distribution
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