Molecular Diagnostic Control Panel BioFire RP2.1 / RP2.1 Plus Positive Level / Negative Level 12 X 300 µL

Features

• Manufacturer: Maine Molecular Quality Controls Inc M441
• BioFire RP2.1/RP2.1plus Control Panel M441 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire® Respiratory Panel 2.1 (RP2.1) and BioFire® Respiratory Panel 2.1plus (RP2.1plus) assay performed on the BioFire FilmArray® 2.0/Torch
• BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1 assay and BioFire RP2.1plus assay
• This product is not intended to replace manufacturer controls provided with the device
• 6 Positive controls and 6 Negative controls
• Quality control materials should be used in accordance with local, state, federal regulations and accreditation requirements
• The BioFire RP2.1/RP2.1plus Control Panel M441 is intended for in vitro use as reference material to monitor the detection and identification of respiratory viral and bacterial targets in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections