BD FOX™ PCR Extraction Tubes 444089

GUDID 00382904440893

BD FOX™ PCR Extraction Tubes

BECTON, DICKINSON AND COMPANY

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00382904440893
• NIH Device Record Key: 51ca1fda-60c4-4480-bca3-52f0c20849e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD FOX™ PCR Extraction Tubes
• Version Model Number: 444089
• Catalog Number: 444089
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 384
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904440893 [Unit of Use]
GS1	30382904440894 [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: 2020-02-27
• Device Publish Date: 2020-02-19

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