Vietnam MOH registration 240002586/PCBB-HN

Quantitative Cystatin C Test Kit

VN: Thuốc thử xét nghiệm định lượng Cystatin C

Finecare™ Cys C Rapid Quantitative Test

Vietnam·Risk Class TBYT Loại B·Cys C Rapid Quantitative Test·Guangzhou Wondfo Biotech Co., Ltd.·Registered Oct 01, 2024

Registration details

Analysis ID: 240002586/PCBB-HN
Submission ID: 000.00.19.H26-240927-0010
Product Type: Cys C Rapid Quantitative Test
Product Code: W219

Company information

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Product Owner: Guangzhou Wondfo Biotech Co., Ltd.
Authorized Representative: CÔNG TY TNHH AVANTA DIAGNOSTICS

Technical details

Intended Use: Finecare™ Cys C Rapid Quantitative Test is a fluorescent immunoassay test used in conjunction with the Finecare™ FIA (Model: FS-113, FS-114, FS-205) Fluorescent Immunoassay Instrument to measure the quantitative concentration of Cystatin C (Cys C) in whole blood, serum, and plasma samples from humans. The test is used as a supportive tool to predict the risk of chronic kidney disease. For professional in-vitro diagnostic use only.

Dates and status

Registration Date: Oct 01, 2024

About this record

Access comprehensive regulatory information for Quantitative Cystatin C Test Kit 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 240002586/PCBB-HN and manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.

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