SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）

Primary DI

06971348761080

Basic UDI-DI Code

B-06971348761080

Reference

MF-91-1

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Shenzhen Microprofit Biotech Co., Ltd.

The fluorecare® SARS-CoV-2 Antigen Test Kit is applicable to the qualitative detection novel Coronavirus (SARS-CoV-2) Antigen in population saliva samples in vitro. It is intended as an aid in the diagnosis of coronavirus infection disease (COVID-19) for symptomatic patients within 7 days after onset of symptoms, which is caused by SARS-CoV-2. For in vitro diagnostic use only. For self-testing use. This kit is suitable for people over 2 years old.People under the age of 2-12 cannot operate by themselves. This kit should be used by adults or parents (18-60 years old) for sample collection and testing. People aged 13-17 can use this kit to collect samples and test samples under the supervision of adults or parents (18-60 years old). Supervisors should ensure that users have a detailed understanding of the requirements of the instructions and watch whether the user's operation is correct. For people over 75 years old, it is recommended that family members or guardians (18-60 years old) use this kit to collect samples and test samples.

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