CG2 Wsh 100588
CG2 Wsh 100588 is a Class III device made by Exact Sciences Corporation, approved under FDA PMA P230043 on 3 Oct 2024 and listed in FDA GUDID since 19 Feb 2025 (UDI-DI 00858637005925), active as of 22 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858637005925 | Date19 Feb 2025 | StatusListed |
| United States | FDA PMAAPPR | NumberP230043 | Date3 Oct 2024 | StatusActive |
Official records
- AccessGUDID record 00858637005925
- FDA PMA database P230043
Across registries
- FDA PMA P230043 decided 3 Oct 2024 Active
- FDA GUDID UDI-DI 00858637005925 listed 19 Feb 2025 Listed
Timeline
- Approved FDA PMA P230043
- Listed FDA GUDID 00858637005925
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- CG2 Wsh
- Generic name
- Faecal occult blood IVD, reagent
- Model / reference
- 100588
- Primary DI / UDI-DI
- 00858637005925
- PMA number
- FDA product code
- PHP
- GMDN term
- Faecal occult blood IVD, reagent
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection).