QuickVue 0W009
by Quidel Corp.
QuickVue 0W009 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K991747 on 4 Aug 1999 and listed in FDA GUDID since 12 Jan 2018 (UDI-DI 30014613320098), 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 | Number30014613320098 | Date12 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991747 | Date4 Aug 1999 | StatusActive |
Official records
- AccessGUDID record 30014613320098
- FDA 510(k) database K991747
Across registries
- FDA 510(k) K991747 decided 4 Aug 1999 Active
- FDA GUDID UDI-DI 30014613320098 listed 12 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K991747
- Listed FDA GUDID 30014613320098
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuickVue
- Generic name
- Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- 0W009
- Primary DI / UDI-DI
- 30014613320098
- 510(k) Number
- FDA product code
- LYR
- GMDN term
- Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
- Device class
- Class I
- Regulation number
- 866.3110
- GUDID distribution status
- In Commercial Distribution
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