Ansh Labs, LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0842-2021Class IIAnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IDecember 18, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
DEN180004picoAMH ELISAOctober 24, 2018