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Quantitative HbA1c Control Testing Material - Vietnam Registration 240000037/PCBB-BYT

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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240000037/PCBB-BYT
Registration Details
Vietnam MOH Registration: 240000037/PCBB-BYT
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Device Details

Quantitative HbA1c Control Testing Material
VN: Vật liệu kiểm soát xét nghiệm định lượng HbA1c
Risk Class TTBYT Loại B

Registration Details

240000037/PCBB-BYT

000.00.04.G18-240313-0008

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Ortho-Clinical Diagnostics, Inc.

Technical Details

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

Mar 14, 2024

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