SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based)

Primary DI

06973315730570

Basic UDI-DI Code

B-06973315730570

Reference

C9602CA

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Nanjing Vazyme Medical Technology Co.,Ltd.

The SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based) is an in vitro diagnostic medical device for the qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B virus in nasopharyngeal swab and nasal 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 SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based) is intended for use by qualified or trained laboratory personnel.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).