Biocartis Nv
FDA Regulatory Profile
Biocartis Nv appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0836-2025, Class II) was initiated on December 10, 2024. Its most recent 510(k) clearance was granted on February 27, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0836-2025 | Class II | Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various ty | December 10, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211181 | Idylla MSI Test | February 27, 2023 |