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Fast PCR Mini Respiratory Panel External Control Kits, Small Format (5Pos+5Neg)

AMDI-0064 · Autonomous Medical Devices Incorporated

The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only.

Details

Device typeMultiple-genus respiratory virus nucleic acid IVD, control: A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

FDA categoryAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Device ID00850025770132

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone(657) 660-6800

Emailcustomerservice@amdilabs.com

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