Biocartis Nv

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0836-2025Class IIIdylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various tyDecember 10, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K211181Idylla MSI TestFebruary 27, 2023