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Visby Medical

Accurate PCR results without the instrument

Test to treat in a single
patient visit.

Instrument-free PCR for respiratory health

Easy to use

One swab, three targets: COVID-19, influenza A and influenza B


No maintenance or service contracts


Easy to run multiple test devices at the same time

Three critical targets

COVID-19 and flu are highly contagious respiratory illnesses. The Visby Medical Respiratory Health Test can differentiate between the causative viruses and give answers to help guide providers toward the most effective treatments.

Flu A

According to the CDC, molecular assays, including RT-PCR, are recommended for testing respiratory tract specimens from hospitalized patients because of their high sensitivity and high specificity.

Flu B

The Infectious Diseases Society of America (IDSA) recommends use of rapid influenza molecular assays over rapid influenza diagnostic tests (RIDTs) for detection of influenza viruses in respiratory specimens of outpatients.


The current gold standard is to perform reverse-transcription polymerase chain reaction (PCR) on nasopharyngeal samples. Best-in-class assays demonstrate a limit of detection (LoD) of approximately 100 copies of viral RNA per milliliter of transport media.

as surges happen

The instrument free Visby Medical Respiratory Health Test allows testing for COVID-19 and flu where it’s most effective, at the point of care.

How to use the Visby Medical Respiratory Health Test

Less than 15 seconds of hands-on time. Results in under 30 minutes.

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Product details

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.