Epitope Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0426-2021Class IIEDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qOctober 1, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K051806CARE FECAL OCCULT BLOOD TEST, MODEL KT313October 3, 2005