FDA Product Code QVR: Multiplex Nucleic Acid Detection System For Biothreat Agents
A Multiplex Nucleic Acid Detection System For Biothreat Agents Is A Qualitative In Vitro Diagnostic Test For Detection And Identification Of Nucleic Acids From Biothreat Pathogens In Human Clinical Specimens
Leading manufacturers include Biofire Defense, LLC and T2biosystems, Inc..
2
Total
2
Cleared
328d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Multiplex Nucleic Acid Detection System For Biothreat Agents Devices (Product Code QVR)
2 devices
Cleared
Sep 15, 2023
T2 Biothreat Panel
T2biosystems, Inc.
Microbiology
130d
Cleared
Mar 22, 2023
BioFire Global Fever Special Pathogens Panel
Biofire Defense, LLC
Microbiology
526d
About Product Code QVR - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QVR since 2023, with 2 receiving FDA clearance (average review time: 328 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.