510(k) DEN170017
DEN170017 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC for the device "FilmArray Respiratory Panel 2 plus (RP2plus)". The FDA issued a decision of De Novo Granted on November 24, 2017. The device falls under product code PZF (Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System), a Class II device regulated under 21 CFR 866.4001. Biofire Diagnostics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 24, 2017
- Date Received
- March 16, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.4001
- Review Panel
- MI
- Submission Type
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.