Rapid SARS-CoV-2 Influenza A+B Antigen Duo Test Card

Organization name

MP Biomedicals Germany GmbH

SRN

DE-MF-000020991

Manufacturer status

Active

Primary placement in Germany; available across 1 country total.

Trade name

Rapid SARS-CoV-2 Influenza A+B Antigen Duo Test Card

UDI-DI code

04260163315984

Basic UDI-DI

B-04260163315984

Reference / catalog number

07AG6020FL

Issuing entity

GS1

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

Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card is an immunochromatography based one step in-vitro test. It is designed for the rapid qualitative and differential detection of SARS-CoV-2, Influenza type A and type B viral antigen in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs from individuals that suspected of respiratory infection. Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card cannot be used as the basis to diagnose or exclude SARS-CoV-2 infection and influenza infection. Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card detects the nucleocapsid protein (N protein) of SARS-CoV-2, Influenza A and Influenza B. Theoretically, genetic SARS-CoV-2 variants with non-nucleocapsid protein mutations do not affect the product performance.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0105099004INFLUENZA A AND /OR B - RT & POC