Vietnam MOH registration 2402935ĐKLH/BYT-HTTB

Qualitative antibody test for HLA class 1 & 2 antigens

VN: Thuốc thử xét nghiệm định tính kháng thể kháng kháng nguyên HLA lớp 1 & 2

LABScreen™ Mixed Class I & II

Vietnam·Risk Class TTBYT Loại C·LABScreen™ Mixed Class I & II·ONE LAMBDA, INC.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402935ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230819-0004
Product Type: LABScreen™ Mixed Class I & II
Product Code: LSM12

Company information

Manufacturer: ONE LAMBDA, INC.
Manufacturer Country: UNITED STATES
Product Owner: ONE LAMBDA, INC.
Authorized Representative: CÔNG TY TNHH CA NA RO

Technical details

Intended Use: Designed for the detection of HLA-antibodies by flow cytometry technology.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Qualitative antibody test for HLA class 1 & 2 antigens 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 2402935ĐKLH/BYT-HTTB and manufactured by ONE LAMBDA, INC.. The authorized representative in Vietnam is CÔNG TY TNHH CA NA RO.

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.