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Nmic-312

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
NMIC-312 FDA UDI
Generic Name
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Device Name
NMIC-312 FDA UDI
Model / Reference
449082 FDA UDI
Description
NMIC-312 FDA UDI

Identifiers

Catalog Number
449082 FDA UDI
Primary DI / UDI-DI
30382904490820 FDA UDI
510(k) Number
K020322 FDA UDI
K023444 FDA UDI
K023634 FDA UDI
K023858 FDA UDI
K033458 FDA UDI
K042932 FDA UDI
K060214 FDA UDI
K060257 FDA UDI
K060444 FDA UDI
K060447 FDA UDI
K061327 FDA UDI
K061355 FDA UDI
K062207 FDA UDI
K062944 FDA UDI
K062945 FDA UDI
K063486 FDA UDI
K063573 FDA UDI
K063811 FDA UDI
K063824 FDA UDI
K123404 FDA UDI
K132674 FDA UDI
K132909 FDA UDI
K163637 FDA UDI
K173252 FDA UDI
K173523 FDA UDI
K181665 FDA UDI
K233986 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

Nmic-312 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

K020322 also covers:

K023444 also covers:

K023634 also covers:

K023858 also covers:

K033458 also covers:

K042932 also covers:

K060214 also covers:

K060257 also covers:

K060444 also covers:

K060447 also covers:

K061327 also covers:

K061355 also covers:

K062207 also covers:

K062944 also covers:

K062945 also covers:

K063486 also covers:

K063573 also covers:

K063811 also covers:

K063824 also covers:

K123404 also covers:

K132674 also covers:

K132909 also covers:

K163637 also covers:

K173252 also covers:

K173523 also covers:

K181665 also covers:

K233986 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 e831534d-24e6-473a-9fe3-b3696fc5626f 37 fields · synced Jun 1, 2026