Rapid Flu A Test

Trade name

Rapid Flu A Test

06936155803804

B-06936155803804

Reference / catalog number

ITP081001-TC20

GS1

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 Rapid Flu A Test is a colloidal gold enhanced, rapid immunoassay for the qualitative detection of influenza A viral nucleoprotein antigens in throat swab specimens. The test is intended for healthcare professional use only. Influenza infection is an acute feverish viral infection that mainly affects the respiratory tract and may occur as an epidemic or pandemic; influenza A is clinically and epidemiologically important because of its association with serious clinical courses and epidemic spread. The test uses a two-site sandwich immunoassay principle. If influenza A viral antigens are present in the sample, they form complexes with mouse monoclonal IgG antibodies to influenza A nucleoproteins conjugated to colloidal gold. The complexes are captured by anti-influenza A antibody immobilized on the nitrocellulose membrane, producing a visible test line. The control line must appear for the result to be valid.

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.

• W0105099004INFLUENZA A AND /OR B - RT & POC

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

• Caution

  For professional in vitro diagnostic use only. Follow the package insert carefully. Follow clinical and laboratory safety guidelines in the collection, handling, storage and disposal of patient specimens and all items exposed to patient specimens. If infection with a novel influenza virus is suspected, specimens should be collected with appropriate infection control precautions and sent to the appropriate health authorities for testing

• Consult instructions for use

  Read and follow the package insert carefully before use

• Biological risks

  Treat patient specimens and exposed items according to laboratory safety precautions and dispose of used materials appropriately

• Do not re-use

  Swabs, tubes and test sticks are for single use only;

• 1. The buffer/extraction buffer contains sodium azide as a preservative. If solution contacts skin or eyes, flush with ample water. Sodium azide may react explosively with lead or copper plumbing; flush discarded solutions with large quantities of water 2.Do not interchange or mix components from different kit lots 3.Do not use past indicated date: Do not use test sticks and reagents after expiration date;