BDXpert™ System 444957
by Becton, Dickinson and Company
BDXpert™ System 444957 is a Class II device made by Becton, Dickinson and Company, cleared under FDA 510(k) K250344 on 6 Mar 2025 and listed in FDA GUDID since 20 Mar 2025 (UDI-DI 00382904449575), active as of 26 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 | Number00382904449575 | Date20 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250344 | Date6 Mar 2025 | StatusActive |
Official records
- AccessGUDID record 00382904449575
- FDA 510(k) database K250344
Across registries
- FDA 510(k) K250344 decided 6 Mar 2025 Active
- FDA GUDID UDI-DI 00382904449575 listed 20 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K250344
- Listed FDA GUDID 00382904449575
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BDXpert™ System
- Generic name
- Microorganism identification/antimicrobial-susceptibility analyser IVD
- Model / Ref / Catalog
- 444957
- Primary DI / UDI-DI
- 00382904449575
- 510(k) Number
- FDA product code
- LON
- GMDN term
- Microorganism identification/antimicrobial-susceptibility analyser IVD
- Device class
- Class II
- Regulation number
- 866.1645
- GUDID distribution status
- In Commercial Distribution