BD Onclarity HPV Self Collection Diluent Tube 445416

GUDID 00382904454166

BD Onclarity HPV Self Collection Diluent Tube

BECTON, DICKINSON AND COMPANY

Human papillomavirus (HPV) nucleic acid IVD, reagent

• Primary Device ID: 00382904454166
• NIH Device Record Key: 3d0619ff-933d-42ce-85a6-37af408c785f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Onclarity HPV Self Collection Diluent Tube
• Version Model Number: 445416
• Catalog Number: 445416
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 400
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904454166 [Unit of Use]
GS1	30382904454167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160037

FDA Product Code

• MAQ: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

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: 2024-11-11
• Device Publish Date: 2024-11-01

Devices Manufactured by BECTON, DICKINSON AND COMPANY

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• 60382904455707 - BD BACTEC™ 9120: 2024-11-12 BD BACTEC™ 9120
• 00382904458003 - BD BACTEC™ 9050: 2024-11-11 BD BACTEC™ 9050
• 00382904454166 - BD Onclarity HPV Self Collection Diluent Tube: 2024-11-11BD Onclarity HPV Self Collection Diluent Tube
• 00382904454166 - BD Onclarity HPV Self Collection Diluent Tube: 2024-11-11 BD Onclarity HPV Self Collection Diluent Tube
• 00382906639844 - Horizon: 2024-10-22 CD138 (MI15) BV421 ASR
• 00382906651204 - Horizon: 2024-10-22 CD197 (2-L1-A) APC-R700 ASR
• 00382906651297 - Horizon: 2024-10-22 CD194 (1G1) BV421 ASR
• 00382906651334 - Horizon: 2024-10-22 CD40 (5C3) BV605 ASR