123145-01-102

Trade name

not provided

UDI-DI code

06974167892140

Basic UDI-DI

697416789123145ZT

Reference / catalog number

123145-01-102

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

1

Additional product description

Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA) is an immunochromatography based one step in vitro test. It is designed for differentiation and qualitative detection of the SARS-CoV-2 virus, Influenza A virus, Influenza B virus, Adenovirus, Respiratory syncytial virus, Parainfluenza virus, Human rhinovirus, metapneumovirus in human anterior nasal swab samples. The test results are used for the auxiliary diagnosis of respiratory pathogen infections, and are suitable for people with clinical symptoms such as fever, sore throat, cough, runny nose. The test kit is designed for use as self-testing. This test kit can be used independently by individuals who are 18 or older. For those under the age of 18, it should be operated or supervised by an adult. This test kit is not used in combination with other equipment and is not automated

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

  EUDAMED did not publish a description for this code.