FDA Authorized Covid19 Test Kits

Covid19 Test Kits are Now Available for Purchase

FDA authorized COVID19 IGG IGM Rapid Antibody test kits are distributed under the emergency use authorization and are 97.19% effective and detecting the Covid-19 antibody within 10 minutes. Tests manufactured in the United States are also available. FDA authorized Covid19 test kits come in boxes of 100.

FDA authorized COVID19 IGG IGM Rapid Test Kit / Antibody test kits are in high demand. If you are serious please contact Medek Health Systems team to get product specifications and pricing. All orders go into allocation based on purchase orders.

FDA authorized Covid19 Test Kits Direct Contact

702-612-4052

COVID19 Test Kit Contact Request Form

COVID19 IGG / IGM Rapid Test Kit / Antibody test kits​

To support public health and safety we are offering a proven cost effective FDA authorized coronavirus test kit to help stop the spread of coronavirus.

  • FDA Authorized Covid19 test kits​
  • Rapid covid test kits results in 10 minutes
  • Small smaple sizes
  • Sold in packs of 100
  • 24 month shelf life
  • Forensic/ Medical Professional use only
  • Test to be performed in a CLIA
FDA authorized Covid19 test kits

FDA authorized COVID19 IGG IGM Rapid Antibody test kits​ Limitations of Sale:

● Rapid results in 10-15 minutes
● Sold in packs of 25 or 100
● Shelf life of 24 months from manufacture date
● For use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
● Verification of use case prior to shipping is mandatory

Governance for COVID19 Test Kits

A. Authorized by the Food and Drug Administration (“FDA”) on May 29, 2020 for detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), or serum.
B. PolicyforDiagnosticTestsforCoronavirusDisease-2019duringthePublic Health Emergency issued on the web on March 16, 2020 by U.S. Food and Drug Administration (FDA”) which may be found here https://www.fda.gov/media/135659/download (collectively the “Policy”);
C. The Policy provides guidance on the emergency use of products for Covid 19 tests in this declared emergency, and provides authority to provide Covid 19 Rapid Cassette IgG/IgM tests (“Products”) and submitted an Emergency Use Authorization to the FDA in compliance with the Policy;

Compliance

A. All sales of Products are subject to the purchaser’s compliance with the Policy and that the Products shall only be used by health professionals as defined in subsection (g) at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=810.2;

C. The Products are only for preliminary screening purposes and shall only be used to determine if additional testing is required

Buyer Requirements

A. Qualified parties who agree to follow the guidance in the Policy including, but not
limited to, validation, FDA notification, reporting of results, Emergency Use Authorization, clinical testing and distribution