QuickVue iFOB Test
QuickVue iFOB Test (20205) is a Class II device made by Quidel Corp., cleared under FDA 510(k) K021423 on 17 Jun 2002 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613202059), 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 | Number30014613202059 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021423 | Date17 Jun 2002 | StatusActive |
Official records
- AccessGUDID record 30014613202059
- FDA 510(k) database K021423
Across registries
- FDA 510(k) K021423 decided 17 Jun 2002 Active
- FDA GUDID UDI-DI 30014613202059 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K021423
- Listed FDA GUDID 30014613202059
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuickVue
- Generic name
- Faecal occult blood IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- iFOB Test, 20205
- Primary DI / UDI-DI
- 30014613202059
- 510(k) Number
- FDA product code
- KHE
- GMDN term
- Faecal occult blood IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 864.6550
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KHE (REAGENT, OCCULT BLOOD).
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- HELENA COLOSCREEN SELF-TEST by Helena Laboratories, Corp.
- FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST by New Bay Bioresearch Co., Ltd.
- FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T by Tianjin New Bay Bioresearch Co., Ltd.
- HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD by Enzo Biochem, Inc.
- ACCU-CULT FECAL OCCULT BLOOD TEST by Applied Medical Devices, Inc.
- HEMOCCULT ICT by Beckman Coulter, Inc.
- WAKO(TM) PRETEST 6A by Wako Chemicals USA, Inc.
- CAMCO R PAK-GUAIAC by Cambridge Chemical Products, Inc.