PZF · Class II · 21 CFR 866.4001

FDA Product Code PZF: Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

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.

1
Total
0
Cleared
253d
Avg days
2017
Since

FDA 510(k) Cleared Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System Devices (Product Code PZF)

1 devices
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No devices found for this product code.

About Product Code PZF - Regulatory Context