Vietnam MOH registration 240002469/PCBB-HCM

ACTH Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng ACTH

Vietnam·Risk Class TBYT Loại B·Elecsys ACTH·Roche Diagnostics (Suzhou) Ltd.·Registered Oct 28, 2024

Registration details

Analysis ID: 240002469/PCBB-HCM
Submission ID: 000.00.19.H29-241023-0002
Product Type: Elecsys ACTH
Product Code: 08946728214

Company information

Manufacturer: Roche Diagnostics (Suzhou) Ltd.
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: In vitro immunoassay test used to quantify the concentration of adrenocorticotropic hormone (ACTH) in human blood plasma, which is anticoagulated with EDTA. The "ECLIA" (electrochemiluminescence immunoassay "ECLIA") test is used in the cobas e immunoassay analyzers.

Dates and status

Registration Date: Oct 28, 2024

About this record

Access comprehensive regulatory information for ACTH Quantitative Testing Drug in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002469/PCBB-HCM and manufactured by Roche Diagnostics (Suzhou) Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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.