Vietnam MOH registration 240001369/PCBA-HN

Automatic Immune Tissue Fixation Dye Machine

VN: Máy nhuộm hóa mô miễn dịch tự động

Vietnam·Risk Class TTBYT Loại A·TintoStainer Plus Automated System·BIO SB, INC·Registered Jul 10, 2024

Registration details

Analysis ID: 240001369/PCBA-HN
Submission ID: 000.00.19.H26-240703-0019
Product Type: TintoStainer Plus Automated System
Product Code: BSB 7400

Company information

Manufacturer: BIO SB, INC
Manufacturer Country: UNITED STATES
Product Owner: BIO SB, INC
Authorized Representative: CÔNG TY CỔ PHẦN XUẤT NHẬP KHẨU KỸ THUẬT - TECHNIMEX

Technical details

Intended Use: Used in applications of immunohistochemistry (IHC), Mohs IHC (TintoFast IHC), Immunohistochemistry (ICC), Fluorescence Immunohistochemistry (IF) on formalin-fixed tissue, frozen tissue, and cells. The IHC-stained tissue samples are cut thin at 2-3um and placed on a glass slide to proceed with the staining.

Dates and status

Registration Date: Jul 10, 2024

About this record

Access comprehensive regulatory information for Automatic Immune Tissue Fixation Dye Machine 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 240001369/PCBA-HN and manufactured by BIO SB, INC. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN XUẤT NHẬP KHẨU KỸ THUẬT - TECHNIMEX.

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