BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit 255560

GUDID 00382902555605

BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit (90 determinations) Contains: Reagent 1, Reagent A, Control+, Control-

BECTON, DICKINSON AND COMPANY

Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

• Primary Device ID: 00382902555605
• NIH Device Record Key: 3c7f7b5c-5de2-4235-a428-55fcb3adce62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit
• Version Model Number: 255560
• Catalog Number: 255560
• 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	00382902555605 [Primary]

FDA Product Code

• GTJ: ANTISERA, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-07

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 30382903059301 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 12.7mm, 29G, 1mL
• 50382903059329 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 12.7mm, 29G, 0.5mL
• 50382903059343 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 8mm, 30G, 0.5mL
• 30382903059356 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 12.7mm, 29G, 0.3mL
• 30382903059370 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 8mm, 31G, 0.3mL
• 50382903284462 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 6mm, 31G, 1mL
• 50382903284479 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 6mm, 31G, 0.5mL
• 30382903284499 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 6mm, 31G, 0.3mL, 0.5 unit