Vietnam MOH registration 2402896ĐKLH/BYT-HTTB

Sirolimus Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng Sirolimus

Vietnam·Risk Class TTBYT Loại C·Alinity i Sirolimus Reagent Kit·Fujirebio Diagnostics, Inc.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402896ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230615-0005
Product Type: Alinity i Sirolimus Reagent Kit
Product Code: 09P4120

Company information

Manufacturer: Fujirebio Diagnostics, Inc.
Manufacturer Country: UNITED STATES
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI

Technical details

Intended Use: Alinity i Sirolimus Testing is a chemiluminescent microparticle immunoassay (CMIA) used to quantitate sirolimus in the total blood of humans on the Alinity i system. Alinity i Sirolimus Testing is used to support the management of patients undergoing sirolimus therapy for kidney transplantation.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Sirolimus Quantitative Testing Drug in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402896ĐKLH/BYT-HTTB and manufactured by Fujirebio Diagnostics, Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.

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