Thera Test Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2382-2021Class IIEL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128October 5, 2020
Z-2381-2021Class IIEL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129July 30, 2020