• #1163497
  • 97
  • Premier Biotech #RT-CV19-20

Rapid Test Kit COVID-19 IgG / IgM Whole Blood / Serum / Plasma Sample 20 Tests

TEST KIT, COVID-19 IGG/IGM WHOLE BLD/SERUM PLASMA

Features
  • ITEM IS DISCONTINUED AND NO LONGER AVAILABLE
  • THIS TEST HAS NOT BEEN REVIEWED BY THE FDA: https://www.fda.gov/media/135659/download
  • Prior to purchasing please review the attached customer letter under More Information
  • More …
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Product Specifications


McKesson #1163497
Manufacturer #RT-CV19-20
ManufacturerPremier Biotech
Country of OriginUnknown
ApplicationRapid Test Kit
ContentsTest Cassette, Dessicant, Buffer, Sterile Lancet, Alcohol Swab, Disposable Dropper / Capillary, Package Insert
For Use WithFor the Qualitative Detection of SARS-CoV-2 Antibodies in Whole Blood, Serum or Plasma
Number of Tests20 Tests
Reading TypeVisual Read
Sample TypeWhole Blood / Serum / Plasma Sample
TechnologyRapid Chromatographic Immunoassay
Test FormatCassette Format
Test NameCOVID-19 IgG / IgM
Time to Results10 Minute Results
UNSPSC Code41116205
Features
  • ITEM IS DISCONTINUED AND NO LONGER AVAILABLE
  • THIS TEST HAS NOT BEEN REVIEWED BY THE FDA: https://www.fda.gov/media/135659/download
  • Prior to purchasing please review the attached customer letter under More Information
  • The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary SARS-CoV-2 infections
  • The procedure is easy to administer and offers reliable results at 10 minutes that remain valid for 20 minutes
  • 20 Tests per Case
  • On March 16, the U.S. government took an unprecedented step towards access to Coronavirus Disease (COVID-19) testing by allowing developers of certain tests to commercialize the products in the U.S. without the requirement for an FDA approval or Emergency Use Authorization (EUA) - as a result, Premier Biotech has given notice to the FDA of intent to launch the COVID-19 IgG and IgM Rapid Test for whole blood (including fingerstick), plasma and serum, in compliance with the regulation
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus; follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals
More Information