FISH Signal Search and Analysis System and Accompanying Accessories - Vietnam Registration 240000701/PCBA-HN
Access comprehensive regulatory information for FISH Signal Search and Analysis System and Accompanying Accessories 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 240000701/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
240000701/PCBA-HN
000.00.19.H26-240422-0017
Theo theo phụ lục
Theo phụ lục
Technical Details
Used in in vitro diagnostic procedures for the purpose of detecting and analyzing chromosomes and FISH signals with the aid of fluorescent microscope images from cultured and colored cell samples in the interphase and the prophase stages. The system operates with fluorescent samples and the current application techniques and the FISH technique. ASI IVD System, HiFISH does not determine the interphase difference; it does not grade the cells according to quality. It relies on the operator to analyze the digital microscope images. FISHView, an automated scanning and analysis system, is applicable to all types of samples and all types of probes. MetScan is indicated for diagnostic in-tro specimens that are suitable for analysis, including amniotic fluid, peripheral blood, stroma, and bone marrow. Metscan also aims to store the images of colored cells, the interphase and the prophase scans and the detection of the interphase, including the automatic collection of interphase images
Dates and Status
May 07, 2024