Contact us

COVID-19

Product Documentation:

Contact us about this product

COVID-19

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 professional use only.

Key Benefits:

  • Qualitative, rapid detection.
  • Detect COVID-19 infection with a simple and rapid procedure.
  • Room temperature or refrigerated storage (2-30⁰C / 36-86⁰F).
  • All necessary reagents provided & no equipment needed.
  • High sensitivity and specificity.

Specifications:

  • Specimen: Nasal swab, Nasopharyngeal swab, Oral fluid, Whole blood, Serum, Plasma
  • Expiration: 24 months from date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatKit SizeRegulatory StatusIntended Use
Healgen® Rapid COVID-19 Antigen TestANGCCOV-502a-NACassette20 Tests/KitFDA 510(k);
CLIA WAIVED		Professional/Rx
External Controls - Healgen® Rapid COVID-19 Antigen Test/GCCOV-PNxSwab1/10 Positive Control Swab;
1/10 Negative Control Swab		FDA ExemptProfessional/Rx
COVID-19 Ag TestAN/NPGCCOV-502a-NNCassette20 Tests/KitCE-IVDDProfessional/Rx
COVID-19 Ag TestNPGCCOV-502aCassette20 Tests/KitCE-IVDDProfessional/Rx
COVID-19 Ag TestOral FluidGCCOV-702aCassette20 Tests/KitCE-IVDDProfessional/Rx
COVID-19 Ag Test (External Control Included)NPGCCOV-502CaCassette20 Tests/KitCE-IVDDProfessional/Rx
Smart COVID-19 Test DeviceANGCCOV-503aDevice1/2/5/10 Tests/KitCE-IVDDProfessional/Rx
COVID-19 IgG/IgM TestWB/S/PGCCOV-402aCassette20 Tests/KitCE-IVDDProfessional/Rx

AN = anterior nasal swab; NP = nasopharyngeal swab; WB/S/P = whole blood, serum, plasma.

More Products