Cap Sln 100251
Cap Sln 100251 is a Class III device made by Exact Sciences Corporation, approved under FDA PMA P230043 on 3 Oct 2024 (1 earlier submission) and listed in FDA GUDID since 20 Nov 2024 (UDI-DI 00858637005345), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858637005345 | Date20 Nov 2024 | StatusListed |
| United States | FDA PMAAPPR | NumberP230043 | Date3 Oct 2024 | StatusActive |
Official records
- AccessGUDID record 00858637005345
- FDA PMA database P230043
- FDA PMA database P130017
Across registries
- FDA PMA P230043 decided 3 Oct 2024 Active
- FDA GUDID UDI-DI 00858637005345 listed 20 Nov 2024 Listed
Recalls
-
- Terminated Z-2219-2017
Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.
Timeline
- Approved FDA PMA P130017
- Recall initiated FDA recalls Z-2219-2017
- Approved FDA PMA P230043
- Listed FDA GUDID 00858637005345
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Cap Sln
- Generic name
- Nucleic acid extraction/isolation kit IVD
- Model / reference
- 100251
- Primary DI / UDI-DI
- 00858637005345
- 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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