COVID 19
FDA STATUS
Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against public threats by facilitating the availability and use of MCMs needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a public pandemic when there are no adequate, approved, and available alternatives.
ALERCELL PROACTIVE RESEARCH
FDA has issued about 175 EUA authorizations and is in the process of reviewing and terminating some authorizations based on failure to validate through independent NCI review.
Alercell has run its internal validation on several EUA authorized Antibody Tests and has retained only three companies to distribute as the Alercell Research supports that these tests are efficient, valid and have an accuracy superior to 95%.
ALERCELL RELIABILITY
Buying Alercell products means buying a quality test that will not become obsolete.
Alercell has researched the production capacity of various manufacturers. Several manufacturers have developed Tests but have limited industrial capacity. Alercell has the capacity to deliver tests in very large quantities.