Altruan GmbH

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1560-2026Class IIClearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in December 19, 2025
Z-1559-2026Class IIWondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infeDecember 19, 2025
Z-1561-2026Class IIBrand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat December 19, 2025