Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays 441358

GUDID 00382904413583

Swab Male Urethral Specimen Collection

BECTON, DICKINSON AND COMPANY

Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical

• Primary Device ID: 00382904413583
• NIH Device Record Key: a54a0eb1-bed7-4982-a97f-8642c4ba1be8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays
• Version Model Number: 441358
• Catalog Number: 441358
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904413583 [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: 7
• Public Version Date: 2025-08-25
• Device Publish Date: 2016-07-07

On-Brand Devices [Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays]

• 30382904413584: Male Urethral Specimen Collection Kit for the BD ProbeTec™ Chlamydia trachomatis/Neisseria gon
• 00382904413583: Swab Male Urethral Specimen Collection