BD Onclarity™ HPV LBC Diluent Tubes 445328

GUDID 00382904453282

Tube HPV LBC Diluent US ThinPrep 400 ea

BECTON, DICKINSON AND COMPANY

Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent Human papillomavirus (HPV) nucleic acid IVD, reagent

• Primary Device ID: 00382904453282
• NIH Device Record Key: 89c12732-607a-4a68-b196-7f869e5d6e48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Onclarity™ HPV LBC Diluent Tubes
• Version Model Number: 445328
• Catalog Number: 445328
• 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
• 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
• 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	00382904453282 [Unit of Use]
GS1	30382904453283 [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: 2023-11-03
• Device Publish Date: 2023-10-26

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