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BD BACTEC™ MGIT™ 960 SIRE Kit

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD BACTEC™ MGIT™ 960 SIRE Kit FDA UDI
Generic Name
Multiple antimycobacterial minimum inhibitory concentration (MIC) IVD, reagent FDA UDI
Device Name
BD BACTEC™ MGIT™ 960 SIRE Kit, carton of 4 lyophilized drug vials, and 8 SIRE Supplements FDA UDI
Model / Reference
245123 FDA UDI
Description
BD BACTEC™ MGIT™ 960 SIRE Kit, carton of 4 lyophilized drug vials, and 8 SIRE Supplements FDA UDI

Identifiers

Catalog Number
245123 FDA UDI
Primary DI / UDI-DI
00382902451235 FDA UDI
510(k) Number
K003062 FDA UDI
K014123 FDA UDI
FDA Product Code
MJA FDA UDI
GMDN Term
Multiple antimycobacterial minimum inhibitory concentration (MIC) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1640 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Multiple antimycobacterial minimum inhibitory concentration (MIC) IVD, reagent

BD BACTEC™ MGIT™ 960 SIRE Kit by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K003062 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 ba0f7aae-8969-413c-8924-84d284022ff1 37 fields · synced Jun 6, 2026