VIROLOGY - RT & POC - OTHER

Primary DI

06975445472054

Basic UDI-DI Code

B-06975445472054

Reference

SARS-CoV-2 Neutralizing Antibody Rapid Test Device

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

FARMASINO MEDICAL CO., LTD

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. The SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette is a rapid test that utilizes a combination of S-RBD antigen coated colored particles for the detection of neutralizing antibodies to SARS-CoV-2 in human whole blood, serum, or plasma.

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