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QMVClass II

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

21 CFR 866.3966 / Microbiology
FDA source (opens on fda.gov)

QMV is the FDA product code for Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness, a class II device type, regulated under 21 CFR 866.3966. FDA's definition for this code reads: "A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QMV
Device name
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
FDA definition
A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.
Regulation
21 CFR 866.3966
Device class
Class II
Review panel
Microbiology
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 QMV

By decision year
3 clearances under product code QMV with a decision year between 2020 and 2024, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QMV by decision year
YearClearances
20201
20221
20241

Applicants with the most clearances

Product code QMV
Applicants holding the most 510(k) clearances under product code QMV
ApplicantClearances
BioFire Defense, LLC2
Biofire Diagnostics, LLC (Biomerieux)1

Companies listing this code with FDA

Companies whose registered establishments list this code