IVD Functional Thyroid Marker Cluster: TT3, FT3, TT4, FT4, TSH - Vietnam Registration 240002592/PCBB-HN
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.
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Device Details
Registration Details
240002592/PCBB-HN
000.00.19.H26-240927-0033
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Oct 02, 2024