Vietnam MOH registration 240000728/PCBB-HCM

MAUVE Syphilis Test (Quick Antibody Detection for Syphilis)

VN: Test thử nhanh phát hiện kháng thể giang mai ( MAUVE Syphilis Test)

Test thử nhanh phát hiện kháng thể giang mai ( MAUVE Syphilis Test)

Vietnam·Risk Class TTBYT Loại B·InTelos,Inc·Registered Apr 05, 2024

Registration details

Analysis ID: 240000728/PCBB-HCM
Submission ID: 000.00.19.H29-231120-0010
Product Code: Theo phụ lục

Company information

Manufacturer: InTelos,Inc
Manufacturer Country: Theo theo phụ lục
Product Owner: InTelos,Inc
Authorized Representative: CÔNG TY TNHH MEDVISION VIỆT NAM

Technical details

Intended Use: The MAUVE™ Syphilis Test (Whole Blood/Plasma/serum) is a rapid immunoassay test for the qualitative detection of antibodies against the bacterium Treponema pallidum in whole blood, plasma, or serum samples from humans. The kit is intended to be used as a diagnostic aid for syphilis infection.

Dates and status

Registration Date: Apr 05, 2024

About this record

Access comprehensive regulatory information for MAUVE Syphilis Test (Quick Antibody Detection for Syphilis) 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 240000728/PCBB-HCM and manufactured by InTelos,Inc. The authorized representative in Vietnam is CÔNG TY TNHH MEDVISION 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.