Vietnam MOH registration 2403593ĐKLH/BYT-HTTB

IVD Department quantitatively tests MR-proADM

VN: Bộ IVD xét nghiệm định lượng MR-proADM

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024

Registration details

Analysis ID: 2403593ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240801-0025
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: *) 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

Registration Date: Nov 14, 2024

About this record

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.

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