Fully Automated Nucleic Acid Analysis System
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| Brand | Allsheng |
|---|---|
| Origin | Zhejiang, China |
| Model | FCM-1 Automated Membrane Cutting System for Nucleic Acid Kits |
| Intended Use | Post-sealing membrane trimming of strip-format nucleic acid assay kits (e.g., Auto-Pure 20A/20B) |
| Compatibility | Designed for integration with semi-automated microplate heat sealers |
| Regulatory Classification | CE-marked lab automation device for in vitro diagnostic (IVD) kit manufacturing support |
| Compliance | Meets ISO 13485-aligned manufacturing controls for IVD accessory equipment |
| Software Interface | RS-232 serial communication for external process synchronization |
| Brand | Kehua Biosciences (KHB) |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | Aurora mini96 |
| Price Range | USD 21,000 – 28,000 |
| Brand | X-Imaging |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | OEM Manufacturer |
| Region of Origin | Domestic (China) |
| Model | mRNA Synthesis Automation System |
| Pricing | Available Upon Request |
| 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 |
| 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 |
