QuickVue iFOB Test
QuickVue iFOB Test (20204) 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 30014613202042), 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 | Number30014613202042 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021423 | Date17 Jun 2002 | StatusActive |
Official records
- AccessGUDID record 30014613202042
- FDA 510(k) database K021423
Across registries
- FDA 510(k) K021423 decided 17 Jun 2002 Active
- FDA GUDID UDI-DI 30014613202042 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K021423
- Listed FDA GUDID 30014613202042
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuickVue
- Generic name
- Faecal specimen collection kit IVD, home-use
- Model / Ref / Catalog
- iFOB Test, 20204
- Primary DI / UDI-DI
- 30014613202042
- 510(k) Number
- FDA product code
- KHE
- GMDN term
- Faecal specimen collection kit IVD, home-use
- 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).
- COLOCARE by Helena Laboratories, Corp.
- IND ONE STEP OCCULT BLOOD (FOB) TEST by Ind Diagnostics, Inc.
- RESUBMITTED FECATWIN SENSITIVE - FECA-EIA by Labsystems, Inc.
- EZ DETECH-URINE BLOOD TEST STICKS by Self Care Systems, Inc.
- IMMOCARE by Care Diagnostic, Inc.
- ACCESS HEMAWIPE by MEDTECH PRODUCTS, INC.
- FECAL OCCULT SLIDE TEST KIT by Cambridge Chemical Products, Inc.
- OCCULTECH FECAL OCCULT BLOOD RAPID TEST by YD Diagnostics CORP.
- COLOSCREEN-ES by Helena Laboratories, Corp.
- FOB ONE STEP RAPID TEST by Orient Gene Biotech