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

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

21 CFR 866.4001 / Pathology
FDA source (opens on fda.gov)

QDS is the FDA product code for Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System, a class II device type, regulated under 21 CFR 866.4001. FDA's definition for this code reads: "A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens –...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
QDS
Device name
Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
FDA definition
A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities.
Regulation
21 CFR 866.4001
Device class
Class II
Review panel
Pathology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
5

Clearances, product code QDS

By decision year
3 clearances under product code QDS with a decision year between 2018 and 2024, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QDS by decision year
YearClearances
20181
20221
20241

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code