BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens 441357

GUDID 00382904413576

BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab, sterile polyurethane-tipped collection swab, Q? Swab Diluent tube

BECTON, DICKINSON AND COMPANY

Urogenital specimen collection kit IVD, clinical

• Primary Device ID: 00382904413576
• NIH Device Record Key: 1ebd5e4c-5fd8-4a46-bd0e-c09cc6b6aa0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens
• Version Model Number: 441357
• Catalog Number: 441357
• 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	00382904413576 [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: 6
• Public Version Date: 2025-08-25
• Device Publish Date: 2016-05-19

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 00382904413576 - BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens: 2025-08-25BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab, sterile polyurethane-tipped collection swab, Q? Swab Diluent tube
• 00382904413576 - BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens: 2025-08-25 BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab,
• 00382904413583 - Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays: 2025-08-25 Swab Male Urethral Specimen Collection
• 00382903059041 - BD SafetyGlide: 2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• 00382903059058 - BD SafetyGlide: 2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
• 00382903059065 - BD SafetyGlide: 2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 22X1-1/2 RB
• 00382903059096 - BD SafetyGlide: 2025-08-07 SYR 3ML LL W/NDL SFTYGLD 21X1-1/2 RB TW
• 00382903059157 - BD SafetyGlide: 2025-08-07 NEEDLE SFTYGLD 21X1 RB TW
• 00382903059164 - BD SafetyGlide: 2025-08-07 NEEDLE SFTYGLD 25X1 RB