Swab Diluent for the BD ProbeTec™

Basic Information

• Brand Name: Swab Diluent for the BD ProbeTec™
• Primary DI: 30382904413614
• Version / Model: 441361
• Catalog Number: 441361
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 175b35e0-38f1-4651-820f-6b69acf756a6

Device Description

Swab Diluent for the BD ProbeTec™ Qx Amplified DNA 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
47320	Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Chlamydia trachomatis bacteria in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382904413614	GS1
Unit of Use	00382904413613	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081825	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 33 Degrees Celsius