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BD Phoenix™ AST Broth 4.5 mL

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD Phoenix™ AST Broth 4.5 mL FDA UDI
Generic Name
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent FDA UDI
Device Name
BD Phoenix™ AST Broth 4.5 mL FDA UDI
Model / Reference
246011 FDA UDI
Description
BD Phoenix™ AST Broth 4.5 mL FDA UDI

Identifiers

Catalog Number
246011 FDA UDI
Primary DI / UDI-DI
30382902460115 FDA UDI
510(k) Number
K020321 FDA UDI
FDA Product Code
LON FDA UDI
GMDN Term
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 4.5 Milliliter FDA UDI

Category: Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent

BD Phoenix™ AST Broth 4.5 mL by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent.

Cleared under the same submission

K020321 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 b19e66d3-249b-4871-a27d-70148ebbdf12 38 fields · synced May 30, 2026