BD BACTEC™ MGIT™ 960 SIRE Kit 245123

GUDID 00382902451235

BD BACTEC™ MGIT™ 960 SIRE Kit Contains: 1 x 332 µg Streptomycin, 1 x 33.2 µg Isoniazid, 1 x 332 µg Rifampin, 1 x 1660 µg Ethambutol, 8 x 20 mL SIRE 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 ID: 00382902451235
• NIH Device Record Key: ba0f7aae-8969-413c-8924-84d284022ff1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD BACTEC™ MGIT™ 960 SIRE Kit
• Version Model Number: 245123
• Catalog Number: 245123
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382902451235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003062

FDA Product Code

• MJA: SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-05-19

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