Product Code: PZF FDA class 2 21 CFR 866.4001

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

Pathology

The MERS-CoV and Common Respiratory Pathogens Multiplex Nucleic Acid Detection System is a qualitative in vitro diagnostic test for the detection and identification of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and other common respiratory pathogens in human clinical specimens, intended for individuals meeting specific MERS-CoV clinical or epidemiological criteria. It is classified as a Class 2 device under regulation 866.4001, requiring 510(k) premarket notification before marketing, and falls within the Pathology (PA) medical specialty with Microbiology (MI) review. The product code is PZF. It is not an implant and is not life-sustaining.

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Basic Information

Product Code: PZF
Device Class: FDA class 2
Regulation Number: 866.4001
Medical Specialty: Pathology
Review Panel: MI
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

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.