Pure Global

IVD Department quantitatively tests MR-proADM - Vietnam Registration 2403593ĐKLH/BYT-HTTB

Access comprehensive regulatory information for IVD Department quantitatively tests MR-proADM in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403593ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.

This page provides complete technical specifications, regulatory compliance details. 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.

Free Database
Powered by Pure Global AI
300,000+ Devices
2403593ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403593ĐKLH/BYT-HTTB
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

IVD Department quantitatively tests MR-proADM
VN: Bộ IVD xét nghiệm định lượng MR-proADM
Risk Class TTBYT Loại C

Registration Details

2403593ĐKLH/BYT-HTTB

000.00.04.G18-240801-0025

Theo theo phụ lục

Theo phụ lục

Technical Details

*) B·R·A·H·M·S MR-proADM KRYPTOR (Product Code: 829050N): B·R·A·H·M·S MR-proADM KRYPTOR is an automated fluorescent immunoassay to determine the concentration of midregional proadrenomedullin (MR-proADM) in EDTA plasma from humans. The B·R·A·H·M·S MR-proADM KRYPTOR test is intended as a supportive tool, in combination with clinical assessment and other test results, to assess the severity of the disease, the progression of the disease, the response to treatment, the risk of cardiovascular events or death, and to guide patient management in the following conditions: •bacteremia, severe sepsis, and septic shock •lower respiratory tract infections (LRTI), including community-acquired pneumonia (CAP), chronic obstructive pulmonary disease (COPD), and bronchitis, •urinary tract infections (UTI), •renal failure, •acute heart failure (AHF), •chronic heart failure (CHF), •myocardial infarction (MI). *) B·R·A·H·M·S MR-proADM KRYPTOR CAL (Product Code: 082991N): To calibrate the reference standard stored in B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD. *) B·R·A·H·M·S MR-proADM KRYPTOR QC (Product Code: 082992N): To monitor the quality of the test results on the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD instrument.

Dates and Status

Nov 14, 2024