MESA BIOTECH, INC. FAB1100CW-1 Accula Flu A / B Control Kit

The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware

The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus.

The Accula™ SARS-CoV-2 Control Kit provides positive and negative control swabs for use with the Accula™ SARS-CoV-2 Test. Positive swabs are coated with DNA Based Synthetic Oligo. The High Positive Controls contain a level of oligo sufficient to provide a positive result when used with the Accula SARS-CoV-2 Test. The Low Positive Controls contain a lower level of oligo, near the limit of detection of the test, but is sufficient to provide a positive result when used with the Accula™ SARS-CoV-2 Test. When used for quality control in the Accula SARS-CoV-2 Test, these controls are useful as an aid in verifying test and operator performance.