BIS SLN Kit 100316
BIS SLN Kit 100316 is a Class III device made by Exact Sciences Corporation, approved under FDA PMA P130017 on 11 Aug 2014 and listed in FDA GUDID since 27 Aug 2021 (UDI-DI 00858637005574), 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 | Number00858637005574 | Date27 Aug 2021 | StatusListed |
| United States | FDA PMAAPPR | NumberP130017 | Date11 Aug 2014 | StatusActive |
Official records
- AccessGUDID record 00858637005574
- FDA PMA database P130017
Across registries
- FDA PMA P130017 decided 11 Aug 2014 Active
- FDA GUDID UDI-DI 00858637005574 listed 27 Aug 2021 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
- Listed FDA GUDID 00858637005574
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- BIS SLN Kit
- Generic name
- Nucleic acid extraction/isolation kit IVD
- Model / reference
- 100316
- Primary DI / UDI-DI
- 00858637005574
- 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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