BD ProbeTec™ (GC) Qx Amplified DNA Assay

Basic Information

• Brand Name: BD ProbeTec™ (GC) Qx Amplified DNA Assay
• Primary DI: 00382904411244
• Version / Model: 441124
• Catalog Number: 441124
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ab92977d-55c3-47ef-9243-3cebb82715bb

Device Description

BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay

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
52806	Neisseria gonorrhoeae culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea which has been isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904411244	GS1

Customer Contacts

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

Storage Conditions

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