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BDXpert™ System

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BDXpert™ System FDA UDI
Generic Name
Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
Device Name
BDXpert™ System FDA UDI
Model / Reference
444957 FDA UDI
Description
BDXpert™ System FDA UDI

Identifiers

Catalog Number
444957 FDA UDI
Primary DI / UDI-DI
00382904449575 FDA UDI
510(k) Number
K250344 FDA UDI
FDA Product Code
LON FDA UDI
GMDN Term
Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1645 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Microorganism identification/antimicrobial-susceptibility analyser IVD

BDXpert™ System by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microorganism identification/antimicrobial-susceptibility analyser IVD.

Cleared under the same submission

K250344 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI e118f20e-8c16-4683-96b5-36ddca2ba054 36 fields · synced May 30, 2026