Vietnam MOH registration 230000011/PCBB-BYT

IVD Department Quantitative SHBG Testing

VN: Bộ IVD xét nghiệm định lượng SHBG
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Jan 04, 2023
Registration details
Analysis ID
230000011/PCBB-BYT
Submission ID
000.00.04.G18-230101-0004
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Technical details
Intended Use
- ADVIA Centaur SHBG: The ADVIA Centaur SHBG test is an in vitro diagnostic immunoassay for the quantitative determination of the concentration of sex hormone-binding globulin (SHBG) in human serum and plasma, using the ADVIA Centaur CP, ADVIA Centaur XP and ADVIA Centaur XPT systems. It is intended for professional use only. The ADVIA Centaur SHBG test is used as a supportive diagnostic tool in the assessment of androgen disorders. - ADVIA Centaur SHBG CAL: Used in in vitro diagnostic procedures to calibrate the ADVIA Centaur SHBG test on the ADVIA Centaur systems.
Dates and status
Registration Date
Jan 04, 2023
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About this record

Access comprehensive regulatory information for IVD Department Quantitative SHBG Testing 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 230000011/PCBB-BYT and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Beckman Coulter, Inc., Theo theo phụ lục, 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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