The document describes a SARS-CoV-2 IgG and IgM Antibody Combined Test Kit that uses a colloidal gold chromatographic immunoassay. It provides information on the product, manuals, validation data showing 33% accuracy for IgG detection and 100% for IgM detection compared to PCR tests, declarations of conformity, certifications, and contact information for the test kit.
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Original Title
Fluorecare COVID19 IgG&IgM rapid test kit introduction
The document describes a SARS-CoV-2 IgG and IgM Antibody Combined Test Kit that uses a colloidal gold chromatographic immunoassay. It provides information on the product, manuals, validation data showing 33% accuracy for IgG detection and 100% for IgM detection compared to PCR tests, declarations of conformity, certifications, and contact information for the test kit.
The document describes a SARS-CoV-2 IgG and IgM Antibody Combined Test Kit that uses a colloidal gold chromatographic immunoassay. It provides information on the product, manuals, validation data showing 33% accuracy for IgG detection and 100% for IgM detection compared to PCR tests, declarations of conformity, certifications, and contact information for the test kit.
2020-03 SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) Product Introduction SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) English Manual SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) Performance Validation Data
The performance of our test
kit have been validated in 30 positive samples verified by PCR test in Shenzhen CDC.
The positive rate of IgG is 33%
and IgM is 100%. SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) DECLARATION OF CONFORMITY SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) EC REP CERTIFICATE SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) Certificate for Exploration of Medical Products SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) ISO 13485 SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) Test Kit info
*Optional Tubularis, Dropper,
Needles and Alcohol Swabs can be provided all at once.