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| Brand | Autobio |
|---|---|
| Model | Sikun2000 |
| Instrument Type | Second-Generation Sequencing Platform |
| Regulatory Status | CE-IVDR and NMPA-Certified In Vitro Diagnostic Device |
| Form Factor | Benchtop Sequencer |
| Read Length Range | 50–300 bp |
| Data Quality | Q30 ≥ 85%–90% |
| Accuracy | >99.9% Base Call Accuracy (per-cycle consensus) |
| Run Time | As fast as 3.2 hours (dependent on read length and chip configuration) |
| Throughput | Mid-Throughput Chip: 220 million reads (11–66 Gb) |
| High-Throughput Chip | 660 million reads (33–200 Gb) |
| Chemistry | Surface-Based Bridge Amplification with Reversible Dye-Terminator Fluorescence Detection |
| Compliance | Designed and validated per ISO 13485, IEC 62304, and aligned with FDA 21 CFR Part 820 and EU IVDR Annex I essential requirements |
| Brand | Autobio |
|---|---|
| Model | Sikun1000 |
| Instrument Type | Second-Generation Sequencing Platform |
| Regulatory Status | CE-IVD & NMPA-Certified In Vitro Diagnostic Device |
| Form Factor | Benchtop Sequencer |
| Read Length | 50–300 bp |
| Throughput | 110M–330M Reads per Run |
| Data Output | 5–100 Gb per Run |
| Run Time | 3.5–24 h |
| Base Call Accuracy (Q30) | >85%–90% |
| Optical Detection Method | Fluorescence-Based Sequencing-by-Synthesis on Solid-Phase Amplified Flow Cell |
| Compliance | ISO 13485, IEC 62304, FDA 21 CFR Part 820, GLP/GMP-Aligned Data Integrity Framework |
| Brand | Autobio |
|---|---|
| Model | Sikun500 |
| Instrument Type | Second-Generation Sequencing Platform |
| Medical Device Classification | Class III (China NMPA) |
| Form Factor | Benchtop Sequencer |
| Read Length | 50–300 bp |
| Q30 Score | >85–90% |
| Sequencing Accuracy | >99.9% |
| Run Time | 3.5–24 hours |
| Throughput | 60M–170M Reads per Run |
| Data Output | 5–50 Gb per Run |
| Origin | Henan, China |
| Regulatory Status | CE-IVD compliant (pending), NMPA registered |
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