Vietnam MOH registration 220002862/PCBB-BYT

IVD Blood Clotting (Coagulation): Free Protein C, Free Protein S, Antithrombin

VN: Cụm IVD Cầm máu (Đông máu): Protein C, Protein S tự do, Antithrombin

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Aug 24, 2022

Registration details

Analysis ID: 220002862/PCBB-BYT
Submission ID: 000.00.04.G18-220823-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: ♦ HemosIL Protein C is used for the automated colorimetric assay to determine the concentration of Protein C in human plasma (citrate-anticoagulated), performed on the coagulation analyzers of Instrumentation Laboratory (IL). ♦ HemosIL Protein S Activity is used for the automated coagulation assay to quantify the concentration of free Protein S in human plasma (citrate-anticoagulated), performed on the ACL TOP Family, ACL TOP Family 50 Series, ACL Elite/Elite Pro, and ACL 7000 coagulation analyzers. The test is used to support the diagnosis of acquired or hereditary Protein S deficiency. ♦ HemosIL Liquid Antithrombin is used for the automated colorimetric assay to determine the concentration of Antithrombin in human plasma (citrate-anticoagulated), performed on the ACL TOP coagulation analyzers.

Dates and status

Registration Date: Aug 24, 2022

About this record

Access comprehensive regulatory information for IVD Blood Clotting (Coagulation): Free Protein C, Free Protein S, Antithrombin 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 220002862/PCBB-BYT and manufactured by Theo theo phụ lục.

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