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.
| Product Description | Specimen | Catalog No. | Format | Kit Size | Regulatory Status | Self-Testing/OTC or Professional/Rx |
|---|---|---|---|---|---|---|
| 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 Test | AN | GCCOV-502a-NA | Cassette | 20 Tests/Kit | FDA 510(k); CLIA WAIVED | Professional/Rx |
| External Controls - Healgen® Rapid COVID-19 Antigen Test | / | GCCOV-PNx | Swab | 1/10 Positive Control Swab; 1/10 Negative Control Swab | FDA Exempt | Professional/Rx |
| 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 |
| COVID-19 Ag Test | AN/NP | GCCOV-502a-NN | Cassette | 20 Tests/Kit | CE-IVDD | Professional/Rx |
| COVID-19 Ag Test | NP | GCCOV-502a | Cassette | 20 Tests/Kit | CE-IVDD | Professional/Rx |
| COVID-19 Ag Test | Oral Fluid | GCCOV-702a | Cassette | 20 Tests/Kit | CE-IVDD | Professional/Rx |
| COVID-19 Ag Test (External Control Included) | NP | GCCOV-502Ca | Cassette | 20 Tests/Kit | CE-IVDD | Professional/Rx |
| Smart COVID-19 Test Device | AN | GCCOV-503a | Device | 1/2/5/10 Tests/Kit | CE-IVDD | Professional/Rx |
| COVID-19 IgG/IgM Test | WB/S/P | GCCOV-402a | Cassette | 20 Tests/Kit | CE-IVDD | Professional/Rx |
AN = anterior nasal swab; NP = nasopharyngeal swab; WB/S/P = whole blood, serum, plasma.