CORONAVIRUS [obsolete from 2025-01-01]

Primary DI

08800069141018

Basic UDI-DI Code

B-08800069141018

Reference

R4101

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

SG Medical Inc.

ACROSIS COVID-19 Ag (NPS) is an in vitro diagnostic rapid test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasopharyngeal swab. This test is intended for use by medical professionals or trained operators who are proficient in performing tests. The product can be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulations. The test provides only preliminary test results. The test results cannot be used as the sole basis for treatment or other patient management decisions.

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