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BD Phoenix™ SMIC-101

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD Phoenix™ SMIC-101 FDA UDI
Generic Name
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Device Name
BD Phoenix™ SMIC-101 FDA UDI
Model / Reference
448803 FDA UDI
Description
BD Phoenix™ SMIC-101 FDA UDI

Identifiers

Catalog Number
448803 FDA UDI
Primary DI / UDI-DI
30382904488032 FDA UDI
510(k) Number
K032675 FDA UDI
K050745 FDA UDI
K050747 FDA UDI
K050780 FDA UDI
K050865 FDA UDI
K050881 FDA UDI
K050946 FDA UDI
K050982 FDA UDI
K051109 FDA UDI
K051138 FDA UDI
K051204 FDA UDI
K051266 FDA UDI
K051272 FDA UDI
K051692 FDA UDI
K062206 FDA UDI
FDA Product Code
LON FDA UDI
GMDN Term
Bacterial species culture isolate identification/antimicrobial susceptibility profile 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

Category: Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent

BD Phoenix™ SMIC-101 by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent.

Cleared under the same submission

K032675 also covers:

K050745 also covers:

K050747 also covers:

K050780 also covers:

K050865 also covers:

K050881 also covers:

K050946 also covers:

K050982 also covers:

K051109 also covers:

K051138 also covers:

K051204 also covers:

K051266 also covers:

K051272 also covers:

K051692 also covers:

K062206 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 fd3a0566-f671-4d56-ad32-b6bb161afd3d 37 fields · synced Jun 8, 2026