BD Directigen™ Group B Strep Test 255460

GUDID 00382902554608

BD Directigen™ Group B Strep Test Contains: Reagent 1, Reagent A, Control +, Control-

BECTON, DICKINSON AND COMPANY

Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

• Primary Device ID: 00382902554608
• NIH Device Record Key: 661b862d-b431-4188-9584-a471402f55ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Directigen™ Group B Strep Test
• Version Model Number: 255460
• Catalog Number: 255460
• 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: true
• 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	00382902554608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870155

FDA Product Code

• GTZ: ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-25

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