Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Trade name

Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

UDI-DI code

06952062710776

Basic UDI-DI

69520627J017LD

Reference / catalog number

COVAg+FluAB1NST-15

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

15

Additional product description

This product is used for the qualitative detection of SARS-CoV-2, influenza A and influenza B in human nasal swab specimens. It is a non-automated rapid test method for infection. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals. Individuals who test positive should seek follow up care with their physician or healthcare provider as additional testing may be necessary. Users under the age of 15 should complete the test with supervision of an adult. Both symptomatic and asymptomatic infections can be tested.

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

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.