Vietnam MOH registration 2300916ĐKLH/BYT-HTTB

Cyclosporine Quantitative Testing Drug Test

VN: Thuốc thử xét nghiệm định lượng Cyclosporine

Vietnam·Risk Class TTBYT Loại C·ARCHITECT Cyclosporine Reagent Kit·Fujirebio Diagnostics, Inc.·Registered Sep 26, 2023

Registration details

Analysis ID: 2300916ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210717-0017
Product Type: ARCHITECT Cyclosporine Reagent Kit
Product Code: 1L75-25

Company information

Manufacturer: Fujirebio Diagnostics, Inc.
Manufacturer Country: UNITED STATES

Technical details

Intended Use: The ARCHITECT Cyclosporine Reagent Kit is a chemiluminescent microparticle immunoassay (CMIA) used to quantitate cyclosporine in whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine is used in the management of patients who have received a heart, liver, or kidney transplant and are being treated with cyclosporine therapy.

Dates and status

Registration Date: Sep 26, 2023

About this record

Access comprehensive regulatory information for Cyclosporine Quantitative Testing Drug Test 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 2300916ĐKLH/BYT-HTTB and manufactured by Fujirebio Diagnostics, Inc..

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