ViroTrack Sero COVID-19 Total Ab

Primary DI

05714132000139

Basic UDI-DI Code

B-05714132000139

Reference

03VTS02-25

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Blusense Diagnostics ApS

Manufacturer Intended Purpose: ViroTrack Sero COVID-19 Total Ab is an in vitro diagnostic (IVD) immunomagnetic assay (IMA) intended for the quantitative detection of anti-SARS-CoV-2 total human antibodies in human whole blood, serum or plasma as an aid at identifying individuals with an adaptive immune response to SARS-COV-2 indicating recent or prior infection. The cartridge is single-use and intended to be used exclusively in combination with the BluBox reader (Ref.: 60BB01). The system is automated. The assay kit is intended to be used by Healthcare Professionals in a laboratory environment and by Healthcare Professionals in office-like near-patient testing environments, for example in hospitals, clinics, pharmacies, long-term care facilities, primary care settings or General Practitioners offices with the purpose of testing patients of both genders in all age-classes. Results must be confirmed by clinical assessment by an expert physician and/or using another marketed test method.

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