Vietnam MOH registration 240000960/PCBB-HN

PCT Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng PCT

Vietnam·Risk Class TTBYT Loại B·PCT Rapid Quantitative Test·Xiamen Biotime Biotechnology Co., Ltd·Registered May 07, 2024

Registration details

Analysis ID: 240000960/PCBB-HN
Submission ID: 000.00.19.H26-240422-0027
Product Type: PCT Rapid Quantitative Test
Product Code: BT2301

Company information

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd
Product Owner: Xiamen Biotime Biotechnology Co., Ltd
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ VIỆT

Technical details

Intended Use: The PCT Rapid Quantitative Test is used to quantify the concentration of PCT in serum, plasma, or whole blood of humans on the FIA Biotime Immunoassay Fluorescence Immunoassay (FIA) instrument. This test is used as a supportive diagnostic method for the detection of infection.

Dates and status

Registration Date: May 07, 2024

About this record

Access comprehensive regulatory information for PCT Quantitative Testing Drug 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 240000960/PCBB-HN and manufactured by Xiamen Biotime Biotechnology Co., Ltd. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ VIỆT.

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