FDA.reportPublic FDA data

BD BACTEC™ MGIT™ 960 IR Kit

Primary DI
00382902451570
Brand
BD BACTEC™ MGIT™ 960 IR Kit
Company
BECTON, DICKINSON AND COMPANY
Model
245157
Catalog number
245157
Device description
BD BACTEC™ MGIT™ 960 IR Kit, carton of 2 lyophilized drug vials, and 4 SIRE Supplements
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJASUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJASusceptibility Test Powders, AntimycobacterialMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902451570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902451570003829024515703829024515700382902451570

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kitA collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterials against a specific bacterial microorganism, isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838091834NAREMEL, INC.MJA2016-12-09
30382902451151BD BACTEC™ MGIT™ 960 PZA MediumBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451235BD BACTEC™ MGIT™ 960 SIRE KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451259BD BACTEC™ MGIT™ 960 STR 4.0 KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451266BD BACTEC™ MGIT™ 960 INH 0.4 KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451280BD BACTEC™ MGIT™ 960 PZA KitBECTON, DICKINSON AND COMPANYMJA2016-05-19