BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135 250160

GUDID 00382902501602

BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135 (90 determinations) Contains: 30 each Reagent 1, Reagent 2, Reagent A, Control +, Control -.

BECTON, DICKINSON AND COMPANY

Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

• Primary Device ID: 00382902501602
• NIH Device Record Key: 99bab72e-3e02-4771-9dd3-6156e6660215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
• Version Model Number: 250160
• Catalog Number: 250160
• 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: false
• 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
• 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
• 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	00382902501602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920274

FDA Product Code

• GTI: ANTISERA, FLUORESCENT, ALL GROUPS, N. MENINGITIDIS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-07

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