Vietnam MOH registration 2403406ĐKLH/BYT-HTTB

Qualitative Antigen Test Reagent

VN: Thuốc thử xét nghiệm định tính kháng nguyên c
Vietnam flagVietnam·Risk Class TBYT Loại D·Anti-c (Anti-RH4) (Monoclonal) BioClone®·Ortho-Clinical Diagnostics, Inc.·Registered Nov 06, 2024
Registration details
Analysis ID
2403406ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230811-0006
Product Type
Anti-c (Anti-RH4) (Monoclonal) BioClone®
Product Code
713120
Company information
Manufacturer Country
UNITED STATES
Product Owner
Ortho-Clinical Diagnostics
Technical details
Intended Use
Used in in vitro qualitative testing to detect the Rh4 antigen on human red blood cells using monoclonal antibodies.
Dates and status
Registration Date
Nov 06, 2024
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About this record

Access comprehensive regulatory information for Qualitative Antigen Test Reagent in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại D medical device is registered under number 2403406ĐKLH/BYT-HTTB and manufactured by Ortho-Clinical Diagnostics, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including DAY medical SA, ; Haemokinesis Ltd, Lab21 Healthcare Ltd, and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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