PZF — Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System Class II
Classification Details
- Product Code
- PZF
- Device Class
- Class II
- Regulation Number
- 866.4001
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Pathology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170017 | biofire diagnostics | FilmArray Respiratory Panel 2 plus (RP2plus) | November 24, 2017 |