Vietnam MOH registration 240002592/PCBB-HN

IVD Functional Thyroid Marker Cluster: TT3, FT3, TT4, FT4, TSH

VN: Cụm IVD Dấu ấn chức năng tuyến giáp: TT3, FT3, TT4, FT4, TSH

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Nanjing Poclight Biotechnology Co., Ltd·Registered Oct 02, 2024

Registration details

Analysis ID: 240002592/PCBB-HN
Submission ID: 000.00.19.H26-240927-0033
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: Nanjing Poclight Biotechnology Co., Ltd
Authorized Representative: CÔNG TY TNHH Y TẾ VINDRAY

Technical details

Intended Use: HCLIA15106: Total Triiodothyronine (TT3) Test Kit (Homogeneous Chemiluminescence Immunoassay) is used to quantitatively determine total triiodothyronine (TT3) in human serum and plasma. The test kit is used as a diagnostic aid for thyroid disorders. It is intended for professional use in laboratories. It is intended for in vitro diagnostic use only; HCLIA15108: Free Triiodothyronine (FT3) Test Kit (Homogeneous Chemiluminescence Immunoassay) is used to quantitatively determine free triiodothyronine (FT3) in human serum and plasma. The test kit is used as a diagnostic aid for thyroid disorders. It is intended for professional use in laboratories. It is intended for in vitro diagnostic use only; HCLIA15107: Total Thyroxine (TT4) Test Kit (Homogeneous Chemiluminescence Immunoassay) is used to quantitatively determine total thyroxine (TT4) in human serum and plasma. The test kit is used as a diagnostic aid for thyroid disorders. It is intended for professional use in laboratories. It is intended for in vitro diagnostic use only; HCLIA15109: Free Thyroxine (FT4) Test Kit (Homogeneous Chemiluminescence Immunoassay) is used to quantitatively determine free thyroxine (FT4) in human serum and plasma. The test kit is used as a diagnostic aid for thyroid disorders. It is intended for professional use in laboratories. It is intended for in vitro diagnostic use only; HCLIA15110: Thyroid-Stimulating Hormone (TSH) Test Kit (Homogeneous Chemiluminescence Immunoassay) is used to quantitatively determine thyroid-stimulating hormone (TSH) in human serum and plasma. The test kit is used as a diagnostic aid for thyroid disorders. It is intended for professional use in laboratories. It is intended for in vitro diagnostic use only.

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for IVD Functional Thyroid Marker Cluster: TT3, FT3, TT4, FT4, TSH 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 240002592/PCBB-HN and manufactured by Nanjing Poclight Biotechnology Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ VINDRAY.

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.