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PZFClass II

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

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

PZF is the FDA product code for Mers-Cov And Common Respiratory Pathogens 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 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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PZF
Device name
Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
FDA 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.
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
1
Ingested recalls
0

Clearances, product code PZF

By decision year
1 clearance under product code PZF with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PZF by decision year
YearClearances
20171

Applicants with the most clearances

Product code PZF
Applicants holding the most 510(k) clearances under product code PZF
ApplicantClearances
BioFire Diagnostics, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PZF.