Vietnam MOH registration 220001159/PCBA-HCM

IVD Coating, Optical Clarity, and Preservation of Specimens

VN: IVD phủ bảo vệ, tạo độ rõ nét quang học và bảo quản các tiêu bản

Vietnam·Risk Class TTBYT Loại A·VENTANA HE 600 Glass Coverslips·MATSUNAMI GLASS IND., LTD.·Registered May 30, 2022

Registration details

Analysis ID: 220001159/PCBA-HCM
Submission ID: 000.00.19.H29-220526-0037
Product Type: VENTANA HE 600 Glass Coverslips
Product Code: 06711138001

Company information

Manufacturer: MATSUNAMI GLASS IND., LTD.

Technical details

Intended Use: VENTANA HE 600 Glass Coverslips are used on the VENTANA HE 600 instrument. This product is used for the microscopic glass slides of formalin-fixed, paraffin-embedded (FFPE) tissue sections in the staining and protection process, to provide optical clarity and preserve the specimens. The final product (the stained and protected specimen) must be interpreted by a qualified pathologist in conjunction with relevant clinical information and appropriate control materials. This product is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: May 30, 2022

About this record

Access comprehensive regulatory information for IVD Coating, Optical Clarity, and Preservation of Specimens 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 220001159/PCBA-HCM and manufactured by MATSUNAMI GLASS IND., LTD..

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