Vietnam MOH registration 240000011/PCBB-TTH

Immunoassay Fluorescence Analyzer

VN: Máy xét nghiệm hóa miễn dịch phân

Vietnam·Risk Class TTBYT Loại B·SENTiFOB®·SENTINEL CH. S.p.A.·Registered Jul 03, 2024

Registration details

Analysis ID: 240000011/PCBB-TTH
Submission ID: 000.00.18.H57-240610-0001
Product Type: SENTiFOB®

Company information

Manufacturer: SENTINEL CH. S.p.A.
Authorized Representative: CÔNG TY TRÁCH NHIỆM HỮU HẠN THƯƠNG MẠI DƯỢC VÀ TRANG THIẾT BỊ Y TẾ TATA

Technical details

Intended Use: Automated device for quantifying hemoglobin in stool, calprotectin, and other substances in stool using the FOB Gold® and Calia Gold immunochemical stool analysis methods, including the reagents, calibration standards, compatible control materials, and sampling devices for stool and testing

Dates and status

Registration Date: Jul 03, 2024

About this record

Access comprehensive regulatory information for Immunoassay Fluorescence Analyzer in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000011/PCBB-TTH and manufactured by SENTINEL CH. S.p.A.. The authorized representative in Vietnam is CÔNG TY TRÁCH NHIỆM HỮU HẠN THƯƠNG MẠI DƯỢC VÀ TRANG THIẾT BỊ Y TẾ TATA.

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