Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMenarini Silicon Biosystems Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 3401 Masons Mill road, Huntingdon Valley, PA, 19006
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3004153557
- DUNS Number
- —
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Celltracks Autoprep | 9541 | FDA UDI | Class II | Active |
| Celltracks Autoprep | 9541R | FDA UDI | Class II | Active |
| Celltracks Autoprep | 7901003 | FDA UDI | Class II | Active |
| Celltracks Analyzer Ii | 9542 | FDA UDI | Class II | Active |
| CellSave | 7900005 | FDA UDI | Class II | Active |
| Celltracks Autoprep | 9541 | FDA UDI | Class II | Active |
| CellSearch | 7900003 | FDA UDI | Class II | Active |
| CellSearch | 7900001 | FDA UDI | Class II | Active |
| CellSave | 952820 | FDA UDI | Class II | Active |
| Celltracks Analyzer Ii | 9555R | FDA UDI | Class II | Active |
| Celltracks Analyzer Ii | 9555 | FDA UDI | Class II | Active |
| Celltracks Analyzer Ii | 9555 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 20, 2022 | Z-1345-2022 | — | open, classified | High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples |
| Apr 4, 2018 | Z-1530-2018 | — | terminated | Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results. |