Alinity m 09N17-095
Alinity m 09N17-095 is a Class II device made by Abbott Molecular, cleared under FDA 510(k) K202977 on 29 Apr 2022 and listed in FDA GUDID since 19 May 2022 (UDI-DI 00884999048591), 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 | Number00884999048591 | Date19 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202977 | Date29 Apr 2022 | StatusActive |
Official records
- AccessGUDID record 00884999048591
- FDA 510(k) database K202977
Across registries
- FDA 510(k) K202977 decided 29 Apr 2022 Active
- FDA GUDID UDI-DI 00884999048591 listed 19 May 2022 Listed
Timeline
- Cleared FDA 510(k) K202977
- Listed FDA GUDID 00884999048591
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alinity m
- Generic name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
- Model / Ref / Catalog
- 09N17-095
- Primary DI / UDI-DI
- 00884999048591
- 510(k) Number
- FDA product code
- QEP
- GMDN term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
- Device class
- Class II
- Regulation number
- 866.3393
- GUDID distribution status
- In Commercial Distribution