SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test

Primary DI

06970277518697

Basic UDI-DI Code

B-06970277518697

Reference

ISIR-535

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Alltest Biotech.Co.,Ltd.

The SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2Nucleocapsid protein,Influenza A, Influenza B and Respiratory Syncytial Virus(RSV) antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein, Influenza A+B and RSV Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/Influenza A+B/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B and RSV.

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