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COVID-19

Product Documentation:

COVID-19

The COVID-19 tests are in vitro immunochromatographic assay for the rapid, qualitative detection of nucleocapsid protein antigen, IgG/IgM antibodies, neutralizing antibody from SARS-CoV-2 in human whole blood, serum, plasma, nasopharyngeal swab, nasal swab and oral fluid specimens.

Key Benefits:

  • Qualitative, visually read results in 10 to 15 minutes.
  • Detect COVID-19 infection with a simple and rapid procedure.
  • Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
  • All necessary reagents provided & no equipment needed.
  • High sensitivity and specificity.

Specifications:

  • Sensitivity 97.25% / Specificity >99% / Accuracy 98.73%
  • Specimen: Nasal swab, Nasopharyngeal swab, Oral Fluid, Whole blood, serum, plasma
  • Time to Results: 10 to 15 minutes
  • Expiration: 24 months from date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatKit SizeClearance
COVID-19 IgG/IgM Test
WB/S/P
GCCOV-402a
Cassette
25 Tests/Kit
CE-IVDD
SARS-CoV-2 NAb Test
WB/S/P
GCCOV(NAb)-402b
Cassette25 Tests/Kit
CE-IVDD
COVID-19 Ag Test
NP
GCCOV-502a
Cassette20 Tests/Kit
CE-IVDD
COVID-19 Ag Test (External Control included)
NP
GCCOV-502Ca
Cassette1/2/3/5/7/20 Tests/Kit
CE-IVDD
COVID-19 Ag Test
NA
GCCOV-502a-NA
Cassette1/2/3/5/7/10/15/20 Tests/Kit
CE-IVDD
COVID-19 Ag Test
NA
GCCOV-502Ua
Cassette20 Tests/Kit
CE-IVDD
COVID-19 Ag Test
NA
GCCOV-503a
Device1/2/5/10 Tests/Kit
FDA 510(k) CLIA WAIVED
COVID-19 Ag Test
NA/NP
GCCOV-502NN
Cassette
20 Tests/Kit
CE-IVDD
COVID-19 Ag Test
Oral Fluid
GCCOV-702a
Cassette
20 Tests/Kit
CE-IVDD
COVID-19 Ag Self-Test
NA
GCCOV-502a-Hxx
Cassette
1/2/3/5/7/8/10/15/20/25 Tests/Kit
CE-IVDD
COVID-19 Ag Self-Test
Oral Fluid
GCCOV-702a-Hxx
Cassette
1/2/3/5/7/10/15/20 Tests/Kit
CE-IVDD
Digital COVID-19 Ag Test
NA
GCCOV-D503a
Digital Device
1/2/3/5/7/10/15/20 Tests/Kit
CE-IVDD
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