Product code PZF— Pathology
FilmArray Respiratory Panel 2 plus (RP2plus)
- Classification name
- Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
- Device class
- Class 2
- Regulation
- 21 CFR 866.4001
- Advisory panel
- Pathology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PZF
FDA has cleared device under product code PZF, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PZF
Recent clearances under product code PZF
Data sourced from openFDA. This site is unofficial and independent of the FDA.