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| Brand | Leica |
|---|---|
| Origin | Germany |
| Model | CELL DIVE Solution |
| Category | Ultra-Multiplex Tissue Imaging & Spatial Biomarker Quantification System |
| Regulatory Status | CE-IVD compliant (for research use only in US) |
| Software Platform | CELL DIVE Analysis Suite v3.2+ |
| Imaging Modality | Cyclic Immunofluorescence (cycIF) with Automated Staining, Imaging, and Stripping |
| Max Biomarkers per Section | ≥60 |
| Spatial Resolution | Subcellular (≤300 nm lateral resolution with confocal mode) |
| Throughput | Up to 12 tissue sections per run |
| Data Output Format | OME-TIFF, JSON metadata, CSV cell-level feature tables |
| Compliance | ISO 13485 certified manufacturing, FDA 21 CFR Part 11–ready audit trail (software-enabled), GLP/GMP-compatible workflow logging |
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