CG2 Bnd Sln 100700
CG2 Bnd Sln 100700 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 00850057859027), 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 | Number00850057859027 | Date19 Feb 2025 | StatusListed |
| United States | FDA PMAAPPR | NumberP230043 | Date3 Oct 2024 | StatusActive |
Official records
- AccessGUDID record 00850057859027
- FDA PMA database P230043
Across registries
- FDA PMA P230043 decided 3 Oct 2024 Active
- FDA GUDID UDI-DI 00850057859027 listed 19 Feb 2025 Listed
Timeline
- Approved FDA PMA P230043
- Listed FDA GUDID 00850057859027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- CG2 Bnd Sln
- Generic name
- Nucleic acid extraction/isolation kit IVD
- Model / reference
- 100700
- Primary DI / UDI-DI
- 00850057859027
- PMA number
- FDA product code
- PHP
- GMDN term
- Nucleic acid extraction/isolation kit IVD
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
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