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

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

21 CFR 866.3981 / Microbiology
FDA source (opens on fda.gov)

QQX is the FDA product code for Respiratory Specimen Nucleic Acid Sars-Cov-2 Test, a class II device type, regulated under 21 CFR 866.3981. FDA's definition for this code reads: "A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs...". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QQX
Device name
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
FDA definition
A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Regulation
21 CFR 866.3981
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
11
Ingested recalls
0

Clearances, product code QQX

By decision year
11 clearances under product code QQX with a decision year between 2021 and 2025, 2022 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QQX by decision year
YearClearances
20211
20223
20232
20242
20253

Applicants with the most clearances

Product code QQX
Applicants holding the most 510(k) clearances under product code QQX
ApplicantClearances
Roche Molecular Systems Inc3
BioFire Defense, LLC2
Cepheid2
Abbott Molecular, Inc.1
DiaSorin Molecular LLC1
Hologic, Inc.1
Life Technologies Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code