JBAIDS

Basic Information

• Brand Name: JBAIDS
• Primary DI: 00851458005020
• Version / Model: JRPD-ASY-0124
• Catalog Number: JRPD-ASY-0124
• Company Name: BIOFIRE DEFENSE, LLC
• Labeler DUNS: 556915205
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 8c46806e-c282-4514-800b-535889ccffbe
• Distribution End Date: 2021-05-06

Device Description

JBAIDS IVD Tularemia Detection Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
OEH	Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit	Microbiology	866.3280	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50959	Francisella tularensis 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 Francisella tularensis in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Francisella tularensis, the bacteria associated with tularaemia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851458005020	GS1

Customer Contacts

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