QVR · Class II · 21 CFR 866.4000

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
1–2 of 2
Cleared Sep 15, 2023
T2 Biothreat Panel
K231336
T2biosystems, Inc.
Microbiology · 130d
Cleared Mar 22, 2023
BioFire Global Fever Special Pathogens Panel
K213362
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.

QVR devices are reviewed by the Microbiology panel. Browse all Microbiology devices →