FDA product code PZF: Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
PZF is the FDA product code for mers-cov and common respiratory pathogens multiplex nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.4001 and reviewed by the Microbiology panel. Devices under PZF reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System |
| Device class | Class II |
| Regulation | 21 CFR 866.4001 |
| Review panel | MI — Microbiology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
Recalls for PZF devices
openFDA lists no recalls for product code PZF.
Frequently asked questions
What is FDA product code PZF?
PZF is the FDA product code for mers-cov and common respiratory pathogens multiplex nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.4001 and reviewed by the Microbiology panel.
What device class is PZF?
Class II, regulation 21 CFR 866.4001. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PZF
- Run a recall and safety report across every PZF manufacturer
- Watch product code PZF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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