SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

Primary DI

06952062774099

Basic UDI-DI Code

69520627J034LD

Reference

CFRA1ST-1

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

This product is used for the qualitative detection of SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV) and adenovirus antigen in human nasal swab specimens. It is a non-automated rapid test method for infection. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals. Individuals who test positive should seek follow up care with their physician or healthcare provider as additional testing may be necessary. Users under the age of 15 should complete the test with supervision of an adult. Both symptomatic and asymptomatic infections can be tested.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).