The Healgen COVID-19 tests are in vitro immunochromatographic assays for the rapid, qualitative detection of nucleocapsid protein antigen, IgG/IgM antibodies, and neutralizing antibody from SARS-CoV-2 in human whole blood, serum, plasma, nasopharyngeal swab, nasal swab and oral fluid specimens.
For over-the-counter use.
| Product Description | Specimen | Catalog No. | Format | Kit Size | Regulatory Status | Intended Use |
|---|---|---|---|---|---|---|
| Healgen® Heal-Check Rapid COVID-19 Antigen Self-Test | AN | GCCOV-502Ua-Hx | Cassette | 1/2/4/6/8/10 Tests/Kit | FDA 510(k) | Self-Testing/OTC |
| Healgen® Rapid COVID-19 Antigen Self-Test | AN | GCCOV-502a-DRHx | Cassette | 1/2/3/4/5/7/8/10/15/20/25 Tests/Kit | CE-IVDR | Self-Testing/OTC |
AN = anterior nasal swab; NP = nasopharyngeal swab; WB/S/P = whole blood, serum, plasma.