JBAIDS JRPD-ASY-0116

GUDID 00851458005037

Bacillus anthracis nucleic acid IVD, kit, nucleic acid technique (NAT)

Primary Device ID	00851458005037
NIH Device Record Key	a13f5efd-1783-40b3-8fd1-9d1d9c9d5b33
Commercial Distribution Status	In Commercial Distribution
Brand Name	JBAIDS
Version Model Number	JRPD-ASY-0116
Catalog Number	JRPD-ASY-0116
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	00851458005037 [Primary]

NHT	Assay, Nucleic Acid Amplification, Bacillus Anthracis

Steralize Prior To Use	false
Device Is Sterile	false

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