
Thermo Fisher Scientific GeneChip System 3000Dx v.2
FDA 승인 및 IVDR 준수 마이크로어레이 시스템으로 RNA 및 DNA 기반 임상 진단에 사용. 직관적인 GCDC Dx 소프트웨어 제공으로 환자 개인정보 보호 및 규제 요건 충족. 강력한 성능과 원격 모니터링 기능을 갖춘 진단용 플랫폼.
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Applied Biosystems™ GeneChip™ System 3000Dx v.2
The GeneChip System (GCS) 3000Dx v.2 is the first microarray platform that is regulatory cleared for diagnostic use in the United States, Europe, and registered in multiple other countries.
This robust microarray platform is designed for clinical applications and is the only FDA-cleared, IVDR-compliant microarray system for RNA- and DNA-based clinical tests.
Take the Proven Path to Market
The GCS 3000Dx v.2 consists of:
- GeneChip Scanner 3000Dx v.2
- GeneChip Fluidics Station 450Dx v.2
- Workstation with GeneChip Data Collection (GCDC) Dx Software
GCDC Dx Software provides an intuitive user interface designed to meet diagnostic lab needs, ensure patient privacy, and comply with Class II Medical Device regulatory requirements.
Key Software Enhancements
- Updated user interface with remote monitoring capability
- Simplified batch registration of arrays
- Easy management of client OS, applications, and IT security
- Notifications for network path interruptions
- Multi-language support
Clinical Application and Support
The GCS 3000Dx v.2 forms the foundation of the Applied Biosystems clinical toolkit, including cGMP-manufactured microarrays.
Clinical partners can obtain design and development support for commercialization of their own cleared diagnostic products under the partnership program.
제품 사양
| 항목 | 내용 |
|---|---|
| 제품라인 | GeneChip™ |
| 용도(애플리케이션) | GeneChip Array Processing, Scanning, and Analysis |
| 치수 | Fluidics Station: 28 × 16 × 15.8 in (71.1 × 41 × 40.2 cm) Scanner: 13 × 22 × 18 in (33 × 56 × 46 cm) Scanner with Autoloader (door closed): 13 × 21.3 × 24.6 in (33 × 54 × 62.5 cm) |
| 중량 | Fluidics Station: 36 kg Scanner with Autoloader: 47.6 kg |
| 수량 | 1 each |
| Unit Size | Each |
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