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Rapid Diagnostic Test

The qualitative or semi-quantitative in vitro-diagnostic medical devices, used singly or in a small series, which involve non-automated procedures and have been designed to give a accurate result in minutes to 1-2 hours, including antigen-antibody detection (direct agglutination, indirect agglutination, immunochromatography) and molecular methods (direct blotting, polymerase chain reaction).

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