BD BACTEC™ MGIT™ 960 PZA Kit 245128

GUDID 00382902451280

BD BACTEC™ MGIT™ 960 PZA Kit Contains: 2 x 20,000 µg pyrazinamide, 6 x 15 mL PZA Supplement

BECTON, DICKINSON AND COMPANY

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
Primary Device ID00382902451280
NIH Device Record Key4d02c69b-baf0-4625-a897-189831005097
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD BACTEC™ MGIT™ 960 PZA Kit
Version Model Number245128
Catalog Number245128
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382902451280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJASUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-23
Device Publish Date2016-05-19

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