JBAIDS JRPD-ASY-0016

GUDID 00851458005013

Coxiella burnetii nucleic acid IVD, kit, nucleic acid technique (NAT)

Primary Device ID	00851458005013
NIH Device Record Key	3b5db035-5fb8-45b0-b11b-5c1fab646deb
Commercial Distribution Status	In Commercial Distribution
Brand Name	JBAIDS
Version Model Number	JRPD-ASY-0016
Catalog Number	JRPD-ASY-0016
Company DUNS	556915205
Company Name	BIOFIRE DEFENSE, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00851458005013 [Primary]

OVF	Assay, Direct, Nucleic Acid Amplification, Q Fever

Steralize Prior To Use	false
Device Is Sterile	false

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00851458005068	JBAIDS IVD Influenza A & B Detection Kit
00851458005044	JBAIDS IVD Plague Detection Kit
00851458005037	JBAIDS IVD Anthrax Detection Kit
00851458005020	JBAIDS IVD Tularemia Detection Kit
00851458005013	JBAIDS IVD Q Fever Detection Kit
00851458005006	JBAIDS Instrument