PhoenixDx® PCR SARS-CoV-2 IVD – FDA EUA APPROVED

PHOENIXDX® SARS-COV-2 IVD is a real-time RT-PCR-based diagnostic test for the in vitro qualitative detection of 2019-Novel Coronavirus (SARS-CoV-2) in respiratory specimens and sera from patients who meet COVID-19 clinical and/or epidemiological criteria.

PHOENIXDX® SARS-COV-2 IVD detects SARS-CoV-2 RNA in nasopharyngeal and oropharyngeal swab samples during infection. Positive results indicate the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information must be considered to determine the actual patient infection status. Positive results do not exclude bacterial infection or co-infection with other viruses.

Fact Sheets Available for Patients and Healthcare Providers Upon Request:

 

Production availability changes on a regular basis.

Please contact info@medihealthsupply.com for a quote.

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Description

PHOENIXDX® SARS-COV-2 IVD is a real-time RT-PCR-based diagnostic test for the in vitro qualitative detection of 2019-Novel Coronavirus (SARS-CoV-2) in respiratory specimens and sera from patients who meet COVID-19 clinical and/or epidemiological criteria.

PHOENIXDX® SARS-COV-2 IVD detects SARS-CoV-2 RNA in nasopharyngeal and oropharyngeal swab samples during infection. Positive results indicate the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information must be considered to determine the actual patient infection status. Positive results do not exclude bacterial infection or co-infection with other viruses.

Negative results do not exclude a SARS-CoV-2 infection and must not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The use of PHOENIXDX® SARS-COV-2 IVD is intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The kits follow CDC’s and WHO’s latest detection guidelines (03/2020).

Fact Sheets Available for Patients and Healthcare Providers Upon Request:

PLEASE NOTE:

This product is shipped in dry ice and cold chain logistic. Please allow for a delivery time of 5-10 days.

Production availability changes on a regular basis.

Please contact info@medihealthsupply.com for a quote.