Alinity m 09N43-085
Alinity m 09N43-085 is a Class II device made by Abbott Molecular, cleared under FDA 510(k) K212778 on 15 Jul 2022 and listed in FDA GUDID since 29 Aug 2022 (UDI-DI 00884999049499), 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 | Number00884999049499 | Date29 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212778 | Date15 Jul 2022 | StatusActive |
Official records
- AccessGUDID record 00884999049499
- FDA 510(k) database K212778
Across registries
- FDA 510(k) K212778 decided 15 Jul 2022 Active
- FDA GUDID UDI-DI 00884999049499 listed 29 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K212778
- Listed FDA GUDID 00884999049499
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alinity m
- Generic name
- Epstein-Barr virus (EBV) nucleic acid IVD, control
- Model / Ref / Catalog
- 09N43-085
- Primary DI / UDI-DI
- 00884999049499
- 510(k) Number
- FDA product code
- QLX
- GMDN term
- Epstein-Barr virus (EBV) nucleic acid IVD, control
- Device class
- Class II
- Regulation number
- 866.3183
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code QLX (Nucleic acid amplification test for the quantitation of epstein-barr virus (EBV) DNA).
- cobas BKV by Roche Molecular System, Inc.
- cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit by Roche Molecular System, Inc.
- Alinity m EBV (09N43-095) by Abbott Molecular
- Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) by Abbott Molecular