Vitek Ms
by Biomerieux, Inc. 3 variants
510(k) K181412
Vitek Ms is a Class II device made by Biomerieux, Inc., cleared under FDA 510(k) K181412 on 21 Dec 2018, active as of 9 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181412 | Date21 Dec 2018 | StatusActive |
Official records
- FDA 510(k) database K181412
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QBN
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3378
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K181412
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VITEK® MS knowledge base v3.3 | 3.3 | 03573026628154 | — | On the market |
| VITEK® MS SOFTWARE v1.1 VITEK MS SW V1.1 | VITEK MS SW V1.1 | 03573026621698 | — | On the market |
| VITEK® MS SOFTWARE v1.2 VITEK MS SW V1.2 | VITEK MS SW V1.2 | 03573026637200 | — | On the market |
| VITEK®MS VITEKMS SW v1.0 / FlexPrep v1.0 | VITEKMS SW v1.0 / FlexPrep v1.0 | 03573026610418 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code QBN (Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates).