RSV Fast Test Kit (Immunofluorescence Assay)

Primary DI

06954414702712

Basic UDI-DI Code

B-06954414702712

Reference

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Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Getein Biotech, Inc.

RSV Fast Test Kit (Immunofluorescence Assay) is intended for the qualitative detection of RSV antigens in human nasopharyngeal swab or oropharyngeal swab samples. RSV viral antigens are 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 bacterial infection or co-infection with other viruses. For professional use only.

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