Vietnam MOH registration 240001755/PCBB-HCM

IVD Cluster for Diabetes Screening

VN: Cụm IVD Xét nghiệm Đái tháo đường

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Monobind, Inc.·Registered Aug 09, 2024

Registration details

Analysis ID: 240001755/PCBB-HCM
Submission ID: 000.00.19.H29-240802-0034
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Monobind, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Monobind, Inc.
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ FUSION

Technical details

Intended Use: 1.C-Peptide-Insulin Diabetes Panel AccuBind VAST ELISA Test System: A test system used to quantitatively detect the concentration of Insulin or C-Peptide in human serum by enzyme-linked immunosorbent assay (ELISA) 2.C-Peptide AccuBind ELISA Test System: A test system used to quantitatively detect the concentration of C-Peptide in human serum by enzyme-linked immunosorbent assay (ELISA) 3.Insulin Rapid AccuBind ELISA Test System: A test system used to quantitatively detect the concentration of Insulin in human serum by enzyme-linked immunosorbent assay (ELISA) 4.Parathyroid Hormone (PTH) 3rd & 2nd Gen (VAST) Test System: A test system used to quantitatively detect the concentration of Insulin in human serum by enzyme-linked immunosorbent assay (ELISA)

Dates and status

Registration Date: Aug 09, 2024

About this record

Access comprehensive regulatory information for IVD Cluster for Diabetes Screening 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 240001755/PCBB-HCM and manufactured by Monobind, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ FUSION.

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.