COVID-19(SARS-CoV-2) Antigen Test Kit

Trade name

COVID-19(SARS-CoV-2) Antigen Test Kit

UDI-DI code

06978896417612

Basic UDI-DI

B-06978896417612

Reference / catalog number

W-AgH-07S

Issuing entity

GS1

Risk category

IVDD — Self-testing

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

This kit is intended for in vitro qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from both symptomatic and asymptomatic individuals suspected of COVID-19. The kit is suitable for layperson use, children under age of 14 should be supervised or assisted by an adult. Please always seek for assistance and supervision with the test when needed and follow your local guidelines for specimen collection by children.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105099099VIROLOGY - RT & POC - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  Read the relevant instructions of this product completely before the test3月25日 11:35

No certificate specifically references this device's Basic UDI-DI.