Vietnam MOH registration 2300878ĐKLH/BYT-HTTB

Quantitative procalcitonin (PCT) test kit

VN: Bộ xét nghiệm định lượng procalcitonin (PCT)

Vietnam·Risk Class TTBYT Loại C·VIDAS B.R.A.H.M.S PCT·BIOMERIEUX SA·Registered Sep 26, 2023

Registration details

Analysis ID: 2300878ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220630-0015
Product Type: VIDAS B.R.A.H.M.S PCT
Product Code: 30450

Company information

Manufacturer: BIOMERIEUX SA
Manufacturer Country: FRANCE

Technical details

Intended Use: VIDAS® B·R·A·H·M·S PCT™ is an automated test performed on the VIDAS® analyzer to detect human procalcitonin in serum or plasma (lithium heparin) samples by the ELFA (Enzyme-Linked Fluorescent Assay - Enzyme Linked Fluorescent Assay) technique. This test, combined with other test results and clinical assessments, is a valuable tool in the evaluation of critically ill patients on the first day of admission to the Intensive Care Unit (ICU), and in predicting the risk of severe sepsis and septic shock. Used in conjunction with other test results and clinical assessments, VIDAS® B·R·A·H·M·S PCT™ also supports the decision-making process for antibiotic therapy in patients with lower respiratory tract infections (LRTI), including community-acquired pneumonia, acute exacerbations of chronic obstructive pulmonary disease (COPD), and acute bronchitis.

Dates and status

Registration Date: Sep 26, 2023

About this record

Access comprehensive regulatory information for Quantitative procalcitonin (PCT) test kit 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 2300878ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA.

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.