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| Brand | QIAGEN |
|---|---|
| Origin | Germany |
| Model | QIAstat-Dx® |
| Configuration | Integrated Sample-to-Answer Platform with Modular Analyzer Units |
| Cartridge Format | Closed, Single-Use Microfluidic Cartridge |
| Maximum Multiplexing Capacity | 48 Targets per Run |
| Turnaround Time | 30–80 minutes |
| Sample Input Flexibility | Direct swab loading |
| Scalability | Up to 4 Independent Analyzer Modules per System |
| Regulatory Status | CE-IVD marked |
| Brand | QIAGEN |
|---|---|
| Origin | Germany |
| Model | NeuMoDx 288 |
| Throughput | 288 tests/8-hour shift |
| Sample Input Volume | 550 µL (from 1 mL tube) |
| Sample Tube Compatibility | Ø11–18 mm × H60–120 mm |
| Reagent Cartridge Format | Closed, single-use microfluidic cartridge |
| Nucleic Acid Extraction | Magnetic bead-based with NeuDry dry-reagent coating |
| PCR Amplification | Integrated real-time qPCR with 5-plex fluorescence detection per reaction |
| Reaction Volume | 19 µL |
| Thermal Control | Silicon-based heating elements for precise ramping and uniform block temperature |
| Internal Control Monitoring | End-to-end process control from lysis to result interpretation |
| Software Compliance | FDA 21 CFR Part 11–ready audit trail, GLP/GMP-aligned data integrity framework |
| Regulatory Status | CE-IVDR certified, intended for in vitro diagnostic use |
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