510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QVRClass II

Multiplex Nucleic Acid Detection System For Biothreat Agents

21 CFR 866.4000 / Immunology
FDA source (opens on fda.gov)

QVR is the FDA product code for Multiplex Nucleic Acid Detection System For Biothreat Agents, a class II device type, regulated under 21 CFR 866.4000. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QVR
Device name
Multiplex Nucleic Acid Detection System For Biothreat Agents
FDA definition
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
Regulation
21 CFR 866.4000
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QVR

By decision year
3 clearances under product code QVR with a decision year between 2023 and 2026, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QVR by decision year
YearClearances
20232
20261

Applicants with the most clearances

Product code QVR
Applicants holding the most 510(k) clearances under product code QVR
ApplicantClearances
BioFire Defense, LLC1
Cepheid1
T2biosystems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code