AZURE BIOTECH INC

FDA Regulatory Profile

AZURE BIOTECH INC appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1432-2021, Class II) was initiated on March 2, 2021.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1432-2021Class IIAssure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic TMarch 2, 2021