Vietnam MOH registration 240000037/PCBB-BYT

Quantitative HbA1c Control Testing Material

VN: Vật liệu kiểm soát xét nghiệm định lượng HbA1c
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics, Inc.·Registered Mar 14, 2024
Registration details
Analysis ID
240000037/PCBB-BYT
Submission ID
000.00.04.G18-240313-0008
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
Ortho-Clinical Diagnostics, Inc.
Technical details
Intended Use
Used in in vitro diagnostic testing on the VITROS 5,1 FS/4600 and VITROS 5600/XT 7600 systems to monitor the performance of the HbA1c drug test (VITROS HbA1c Reagent Kit)
Dates and status
Registration Date
Mar 14, 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 240000037/PCBB-BYT 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 ARKRAY Factory, 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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