BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit 440476

GUDID 30382904404766

BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit Contains: 100 each polyurethane-tipped swab in tubes, rayon-tipped cleaning swabs

BECTON, DICKINSON AND COMPANY

Urogenital specimen transport medium collection kit Urogenital specimen transport medium collection kit Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical

• Primary Device ID: 30382904404766
• NIH Device Record Key: 85aabfce-a1c7-4ec6-9562-569fa06e5250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit
• Version Model Number: 440476
• Catalog Number: 440476
• 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
• 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
• 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
• 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904404765 [Primary]
GS1	30382904404766 [Package]; Contains: 00382904404765; Package: Shelfpack [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984631

FDA Product Code

• LSL: DNA-REAGENTS, NEISSERIA

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-12

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 50382903649902 - BD Vacutainer® Urinalysis Transfer Straw Kit: 2024-04-18 KIT URIN TRANSTR 16X100 10.0 UA YEL
• 50382903649445 - BD Vacutainer® C&S Boric Acid Kit: 2024-04-17 KIT URIN PLH 16X100 10 C&S KAGN CE
• 50382903649599 - BD Vacutainer® C&S Boric Acid Kit: 2024-04-17 KIT URIN TRANSTR 13X75 C&S KAGN CE HEMO
• 50382903649919 - BD Vacutainer® Urinalysis Transfer Straw Kit: 2024-04-17 KIT URIN TRANSTR 16X100 8.0 CONI UA YEL
• 50382903686556 - BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder: 2024-04-16 Wingset SLBCS 23x.75 7 Preattached
• 50382903689205 - BD Vacutainer® FX 5mg 4mg Blood Collection Tubes: 2024-04-16 TUBE GLU PLH 13X75 2.0 BLBLCE GR
• 50382903689212 - BD Vacutainer® FX 10mg 8mg Blood Collection Tubes: 2024-04-16 TUBE GLU 13X75 4.0 PLH PLBLCE GR
• 50382903649575 - BD Vacutainer® Urine Complete Cup Kit: 2024-04-15 KIT URIN COMP 13X75 C&S 16X100 CONI UAP