Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit

Primary DI

06973315730341

Basic UDI-DI Code

B-06973315730341

Reference

CD502

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Nanjing Vazyme Medical Technology Co.,Ltd.

The Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit is a real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A and influenza B virus in nasopharyngeal swab and oropharyngeal swab specimens. The test is intended for use as an aid in the rapid diagnosis of SARS-CoV-2, influenza A and influenza B virus in humans. Positive results are indicative of SARS-CoV-2, influenza A and influenza B virus; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Negative results do not preclude SARS-CoV-2, influenza A, and influenza B infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. The test provides a preliminary test result only, the final confirmation should be based on clinical diagnostic results. Testing with the Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit is intended for use by qualified or trained laboratory personnel.

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