Vietnam MOH registration 240000923/PCBA-HN

System for chromosome search, analysis, and accompanying accessory components

VN: Hệ thống tìm kiếm, phân tích nhiễm sắc thể và linh phụ kiện đi kèm

Vietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·Applied Spectral Imaging Ltd·Registered May 23, 2024

Registration details

Analysis ID: 240000923/PCBA-HN
Submission ID: 000.00.19.H26-240422-0010
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 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

Registration Date: May 23, 2024

About this record

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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