Test Catalog

PNZIK/65276:
Prenatal Zika Virus IgM Antibody Capture MAC-ELISA, Serum

Test Classification Current Value

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

Test Classification Value Prior to 8/05/2019 4:03pm

This test received Emergency Use Authorization from the U.S. Food and Drug Administration on August 17, 2016. The approval letter can be accessed here: http://www.fda.gov/downloads/medicaldevices/safety/emergencysituations/ucm517143.pdf This test is used per manufacturer's instructions. Details regarding the performance characteristics for the InBios ZIKV Detect IgM Capture ELISA, can be viewed here: http://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM517147.pdf Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.