Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
PZF · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 866.4001
Classification
FDA Product Code
PZF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.4001
Review panel
MI
Medical specialty
Pathology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the detection and identification 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.