System for chromosome search, analysis, and accompanying accessory components - Vietnam Registration 240000923/PCBA-HN
Access comprehensive regulatory information for System for chromosome search, analysis, and accompanying accessory components in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000923/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.
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Device Details
Registration Details
240000923/PCBA-HN
000.00.19.H26-240422-0010
Theo theo phụ lục
Theo phụ lục
Technical Details
Used in in vitro diagnostic procedures to search for and analyze chromosomes with images of fluorescently labeled cells in the interphase. The system operates with bright field samples and all current techniques, including G-Banding and DAPI banding. ASI IVD System, HiBand does not determine the interphase difference; it does not grade cells according to quality. It fulfills the requirements and is completely operator-dependent when working with digital microscopy images. BandView is used to analyze chromosomes and determine the chromosomes, including the image acquisition module. MetScan is indicated for diagnostic in-tro specimens suitable for analysis, including amniotic fluid, peripheral blood, stroma, and bone marrow. Metscan also has the purpose of storing the images of the fluorescently labeled cells, including the interphase, and the automated collection of the interphase images
Dates and Status
May 23, 2024