Vietnam MOH registration 240000762/PCBB-HN

Quantitative HbA1c Control Testing Material

VN: Vật liệu kiểm soát xét nghiệm định lượng HbA1c
Vietnam flagVietnam·Risk Class TTBYT Loại B·ADAMS A1c CONTROL·ARKRAY Factory, Inc.·Registered Apr 12, 2024
Registration details
Analysis ID
240000762/PCBB-HN
Submission ID
000.00.19.H26-240404-0013
Product Type
ADAMS A1c CONTROL
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
ARKRAY Factory, Inc.
Authorized Representative
CÔNG TY TNHH ARKRAY VIỆT NAM
Technical details
Intended Use
ADAMS A1c CONTROL is a specialized control material designed to perform quality control for the automatic glycohemoglobin analyzer, HA-8180V, HA-8180T, HA-8190V and HA-8380V. This product is intended for use in laboratory diagnosis only. Do not use this product for any other purpose.
Dates and status
Registration Date
Apr 12, 2024
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About this record

Access comprehensive regulatory information for Quantitative HbA1c Control Testing Material 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 240000762/PCBB-HN and manufactured by ARKRAY Factory, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ARKRAY VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Ortho-Clinical Diagnostics, Inc., SD Biosensor, Inc., 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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