Product description

STREP A Rapid test for detecting bacterial tonsillitis

A rapid, single-step, flow-through immunoassay for the qualitative detection of group A streptococcal antigen from throat swab specimens to aid in the early diagnosis of group A streptococcal infection. For in vitro use only. For self-administration.

Rapid detection of group A Streptococcus antigens
Non-invasive examination
Result after 10 minutes
Simple interpretation of results
Test sensitivity – 96.6%
Test specificity – 98.9%
Test accuracy – 98.7%
For in vitro diagnostics, for self-use.

Intended use: The Streptococcus A Rapid Test is intended for the detection of group A streptococcus antigen from a throat swab.

PACKAGE CONTENTS

The test package contains:

• single sealed bag (test plate, desiccant bag),
• extraction tube,
• sterile swab,
• bottle of buffer A,
• bottle of buffer B,
• instructions for use.

Additional information:

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.

Authorized representative in the EU: Qarad BV

Importer: Diagnosis SA

Advertising entity: Diagnosis SA

CE 0123

This is a medical device. Use it according to the instructions for use or label.

Important information about the medical device:

• Medical device - has the CE marking.
• It has an EU declaration of conformity
• Includes user manual in Polish
• Includes label in Polish

Storage and transport of medical devices are in accordance with the conditions specified by the manufacturer.

Related articles

Diseases and ailments, Flu and colds

Angina – symptoms, treatment and complications of angina