BD BACTEC™ FX Bottom

FDA UDI

Class I (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name: BD BACTEC™ FX Bottom FDA UDI
Generic Name: Blood culture analyser IVD FDA UDI
Device Name: BD BACTEC™ FX Bottom FDA UDI
Model / Reference: 441386 FDA UDI
Description: BD BACTEC™ FX Bottom FDA UDI

Identifiers

Catalog Number: 441386 FDA UDI
Primary DI / UDI-DI: 00382904413866 FDA UDI
510(k) Number: K915796 FDA UDI
FDA Product Code: MDB FDA UDI
GMDN Term: Blood culture analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 62.2 Centimeter FDA UDI
Depth — 86.9 Centimeter FDA UDI
Height — 93.9 Centimeter FDA UDI

Category: Blood culture analyser IVD

BD BACTEC™ FX Bottom by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K915796 also covers:

BD BACTEC™ FX Top — BECTON DICKINSON AND COMPANY

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Becton Dickinson And Company

Sources (1)

FDA UDI 3b818598-6e03-4350-adac-0751c723c987 38 fields · synced May 30, 2026