The FISH (Fluorescence In Situ Hybridization) search and analysis system comprises the software and accompanying hardware components
Vietnam·Risk Class TBYT Loại A·Theo theo phụ lục·Applied Spectral Imaging Ltd·Registered Nov 13, 2024- Analysis ID
- 240002549/PCBA-HN
- Submission ID
- 000.00.19.H26-241111-0027
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Applied Spectral Imaging Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Applied Spectral Imaging Ltd
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ VÀ ĐẦU TƯ MDC
- Intended Use
- The ASI IVD System, CytoPower is a chromosome search and analysis system, including FISH signal analysis, designed for in vitro diagnostic use. It aims to search and analyze chromosomes and FISH signals from the fluorescent images of cultured and stained cell samples in the interphase and metaphase stages. It is a combined platform of Hiband chromosome analysis and HiFISH digital FISH analysis, which allows the seamless integration of brightfield and fluorescent samples with the current applications. CytoPower automatically scans and analyzes all types of samples and all types of probes. It does not determine the interphase level; it does not rank cells according to quality. It relies on the operator to analyze the digital fluorescence images. The system consists of the following software and accessories: The FPRAC0126 Automatic Slide Loading Unit, which includes the slide loader, the Matrix 120 Barcode Scanner FPRAC0128, the Zebra ZD621T barcode printer FPRAC0155, the Automatic Oil Dispensing Unit FPRAC0127, and the LED light source PE-300. The FPSCN0032 Scanning and Analysis Unit, which includes the Dell Precision 3660 workstation with i7-13700K/16GB no GPU, the acA2440-35um camera, the automatic slide stage, and the software: FPRSF0105 - Case Data Manager™ software for managing data. FPRSF0154 - Aided Karyotyping Scanning & Analysis software for automatic chromosome scanning and analysis. FPRSF0118 - MetScan software for collecting interphase images. FPRSF0117 - SpotScan software for collecting FISH images and analyzing FISH. FPRSF0109 - BandView™ software for chromosome and band analysis with the image collection module. The FPREV0011 Evaluation and Analysis Unit, which includes the Dell Precision 3660 workstation with i7-13700K/16GB no GPU and the software: FPRSF0105 - Case Data Manager™ software for managing data. FPRSF0136 - LabLife software for measuring and managing laboratory performance. FPRSF0119 - MetScan Gallery software for evaluating interphase images. FPRSF0114 - SpotScan software for evaluating and analyzing FISH. FPRSF0110 - BandView™ software for chromosome and band analysis. FPRSF0155 - Aided Karyotyping Analysis software for automatic chromosome classification.
- Registration Date
- Nov 13, 2024
Access comprehensive regulatory information for The FISH (Fluorescence In Situ Hybridization) search and analysis system comprises the software and accompanying hardware components in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240002549/PCBA-HN and manufactured by Applied Spectral Imaging Ltd. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ VÀ ĐẦU TƯ MDC.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.