E25Bio, Inc.

FDA Regulatory Profile

E25Bio, Inc. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0564-2022, Class I) was initiated on January 27, 2022.

Summary

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

Recent Recalls

NumberClassProductDate
Z-0564-2022Class IE25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART KitJanuary 27, 2022