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A reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information to aid towards a diagnosis.

Regulatory Definitions

Tests

MSD V-PLEX SARS-CoV-2 Panel 2 Kit N IgG Serology Assay

A proprietary serology assay that can be used to measure IgG antibodies against the SARS-CoV-2 nucleocapsid protein (N).

For professionals

Tests

MSD V-PLEX SARS-CoV-2 Panel 2 Kit N IgM Serology Assay

A proprietary serology assay that can be used to measure IgM antibodies against the SARS-CoV-2 nucleocapsid protein (N).

For professionals

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Whole Blood DNA Extraction Kit (Magnetic Bead Method)

Zymoclean Gel RNA Recovery Kit

Analytical and clinical performance of a novel DiaRD CMV qPCR assay for cytomegalovirus DNA quantification: a comparative study with the artus CMV RG PCR kit.

CD117 Expression Measurement

Clinical evaluation of the Altostar HDV RT-PCR Kit 1.5.

Clinical performance of the fully automated quantitative LeaDEA Pneumocystis PCR Kit for the diagnosis of Pneumocystis jirovecii pneumonia.

Comparative study of a reference PCR assay targeting kinetoplast DNA and a commercial kit targeting ribosomal DNA for the molecular diagnosis of visceral leishmaniasis.

Evaluation of the clinical performance of the JETest Influenza A/B Antigen Rapid Test Kit versus real-time reverse transcription-PCR for influenza detection.

Evaluation of the GCdiaMTB/NTM real-time PCR kit according to the Korean invitro diagnostic medical device approval standards.

In Vitro Diagnostic Device

MSD V-PLEX SARS-CoV-2 Panel 2 Kit N IgG Serology Assay

MSD V-PLEX SARS-CoV-2 Panel 2 Kit N IgM Serology Assay