Vietnam MOH registration 240001757/PCBB-HCM

Quantitative Antibody Test Kit for Helicobacter Pylori

VN: Bộ xét nghiệm định lượng kháng thể IgG kháng Helicobacter Pylori

Vietnam·Risk Class TTBYT Loại B·H.Pylori Ab IgG Test System·Monobind, Inc·Registered Aug 09, 2024

Registration details

Analysis ID: 240001757/PCBB-HCM
Submission ID: 000.00.19.H29-240802-0032
Product Type: H.Pylori Ab IgG Test System

Company information

Manufacturer: Monobind, Inc
Product Owner: Monobind, Inc.
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ FUSION

Technical details

Intended Use: The test kit is used to quantitatively detect the specific antibodies against H. pylori of the IgG type in human serum or plasma by enzyme-linked immunosorbent assay (ELISA), which measures colorimetrically.

Dates and status

Registration Date: Aug 09, 2024

About this record

Access comprehensive regulatory information for Quantitative Antibody Test Kit for Helicobacter Pylori 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 240001757/PCBB-HCM and manufactured by Monobind, Inc. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ FUSION.

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