Swab Diluent for the BD ProbeTec™ 441361

GUDID 30382904413614

Swab Diluent for the BD ProbeTec™ Qx Amplified DNA Assays

BECTON, DICKINSON AND COMPANY

Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 30382904413614
• NIH Device Record Key: 175b35e0-38f1-4651-820f-6b69acf756a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swab Diluent for the BD ProbeTec™
• Version Model Number: 441361
• Catalog Number: 441361
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 48
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904413613 [Unit of Use]
GS1	30382904413614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081825

FDA Product Code

• LSL: DNA-REAGENTS, NEISSERIA

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-08

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