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

Basic Information

• Brand Name: BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit
• Primary DI: 00382904404765
• Version / Model: 440476
• Catalog Number: 440476
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-12
• Public Version: 6
• Public Version Date: 2023-10-16
• Public Version Status: Update
• Public Device Record Key: 85aabfce-a1c7-4ec6-9562-569fa06e5250
• Distribution End Date: 2022-04-26

Device Description

BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit

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: No
• 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
57937	Urogenital specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of cellular and/or other material collected from the endocervix, vagina, and other male/female lower urogenital area (e.g., urethra) for in vitro diagnostic investigation [e.g., microbiological culture, histopathological cervical cancer screening]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium (e.g., preservative solution, Amies/Stuart transport medium); initial preparation/fixation/preservation materials may also be included in the kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30382904404766	GS1	Shelfpack	100	Not in Commercial Distribution	2022-04-26
Primary	00382904404765	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984631	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius