Vietnam MOH registration 240000701/PCBA-HN

FISH Signal Search and Analysis System and Accompanying Accessories

VN: Hệ thống tìm kiếm, phân tích tín hiệu FISH và linh phụ kiện đi kèm

Vietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·Applied Spectral Imaging Ltd·Registered May 07, 2024

Registration details

Analysis ID: 240000701/PCBA-HN
Submission ID: 000.00.19.H26-240422-0017
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

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

Technical details

Intended Use: 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

Registration Date: May 07, 2024

About this record

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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