BD Vaginal Specimen Transport for the BD ProbeTec™ Qx Amplified DNA Assays

Basic Information

• Brand Name: BD Vaginal Specimen Transport for the BD ProbeTec™ Qx Amplified DNA Assays
• Primary DI: 30382904411221
• Version / Model: 441122
• Catalog Number: 441122
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-07-07
• Public Version: 9
• Public Version Date: 2025-08-11
• Public Version Status: Update
• Public Device Record Key: 2ae05b0a-5067-44de-91e6-9f0411871baa

Device Description

Swab Vaginal Transport CT/GC Qx Assays

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LSL	DNA-REAGENTS, NEISSERIA	Microbiology	866.3390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61144	Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382904411221	GS1
Unit of Use	00382904411220	GS1
Package	50382904411225	GS1	Case	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K081825	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Peel here
• Type: Special Storage Condition, Specify
• Special Conditions: Collection date
• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius