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FDA-CLEARED | 510(k) K262789

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SimplicityDx Panel FluA/FluB/RSV

A multiplex real-time RT-PCR assay that qualitatively detects and differentiates influenza A, influenza B and RSV.

*using ThermoFisher QuantStudio 5 Dx instrumentation

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What it detects

Influenza A

Influenza B

RSV

Panel includes an internal control

Intended Use

The SimplicityDx™ Panel FluA/FluB/RSV is a multiplex real-time RT-PCR assay that qualitatively detects and differentiates influenza A, influenza B and RSV RNA in anterior nasal swab specimens from individuals with signs and symptoms of respiratory infection. Results are intended as an aid in differential diagnosis, alongside other clinical, epidemiologic and laboratory findings.

For prescription use only. For laboratories certified under CLIA to perform high-complexity tests.

Multiplex PCR, Simplified.

A streamlined workflow built for busy labs.

1

Extract

Extract nucleic acids from anterior nasal swab specimens.

2

Plate

Add extracted samples to the ready-to-use plate. No extra reagents to prepare.

3

Run

Run multiplex real-time RT-PCR on a few samples or a full batch.

4

Review

Qualitative results that detect and differentiate influenza A, influenza B and RSV.

The breakaway format is designed to let labs use only the assays needed for each run, with minimal pipetting, and can help reduce waste and simplify inventory.
anticipated-availability

Available to Order Soon

 

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