BD Directigen™ S. pneumoniae Test 251960

GUDID 00382902519607

BD Directigen™ S. pneumoniae 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: 00382902519607
• NIH Device Record Key: 3d67415b-c7c5-4a67-b8ba-020750213708
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Directigen™ S. pneumoniae Test
• Version Model Number: 251960
• Catalog Number: 251960
• 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	00382902519607 [Primary]

FDA Product Code

• GWC: ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-06-25
• Device Publish Date: 2018-05-25

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 30382903673248 - BD Vacutainer® Push Button Blood Collection Set: 2024-07-16 Wingset PBBCS 23x.75 12 w/o Luer
• 30382903673262 - BD Vacutainer® Push Button Blood Collection Set: 2024-07-16 BD Vacutainer® Push Button Blood Collection Set
• 30382903673385 - BD Vacutainer® Push Button Blood Collection Set: 2024-07-16 WINGSET PBBCS 21X.75 7 LUER
• 30382903673415 - BD Vacutainer® Push Button Blood Collection Set: 2024-07-16 WINGSET PBBCS 25X.75 12 LUER
• 30382903673422 - BD Vacutainer® Push Button Blood Collection Set: 2024-07-16 WINGSET PBBCS 23X.75 12 LUER
• 30382903673446 - BD Vacutainer® Push Button Blood Collection Set: 2024-07-16 WINGSET PBBCS 21X.75 12 LUER
• 30382903673521 - BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder: 2024-07-16 WINGSET PBBCS 21X.75 12 PREATTACHED
• 30382903673354 - BD Vacutainer® Push Button Blood Collection Set: 2024-07-15 BD Vacutainer® Push Button Blood Collection Set