COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab)

Trade name

COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab)

UDI-DI code

D-GCFCR-T525Sa-DD4H

Basic UDI-DI

B-GCFCR-T525Sa-DD4H

Reference / catalog number

GCFCR-T525Sa-DD

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative and differential detection of nucleocapsid protein antigen from SARS-CoV-2, influenza A (including the subtype H1N1), influenza B and/or Respiratory Syncytial Virus (RSV) in nasal swab specimens. It is intended to be as an aid in the rapid diagnosis of SARS-CoV-2, influenza A, influenza B and/or RSV infections. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab) must be confirmed with alternative testing method(s) and clinical findings. For in vitro diagnostic use only, For professional use only.

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.

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