JBAIDS

Basic Information

• Brand Name: JBAIDS
• Primary DI: 00851458005013
• Version / Model: JRPD-ASY-0016
• Catalog Number: JRPD-ASY-0016
• 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: 4
• Public Version Date: 2022-04-05
• Public Version Status: Update
• Public Device Record Key: 3b5db035-5fb8-45b0-b11b-5c1fab646deb
• Distribution End Date: 2020-01-22

Device Description

JBAIDS IVD Q Fever 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
OVF	Assay, Direct, Nucleic Acid Amplification, Q Fever	Microbiology	866.3500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51346	Coxiella burnetii 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 Coxiella burnetii in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Coxiella burnetii, the rickettsial bacteria associated with Q fever.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851458005013	GS1

Customer Contacts

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