Vietnam MOH registration 240003019/PCBB-HN

KL-6 Quantitative Test Kit

VN: Bộ xét nghiệm định lượng KL-6

Vietnam·Risk Class TBYT Loại B·Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay)·Nanjing Poclight Biotechnology Co., Ltd.·Registered Nov 04, 2024

Registration details

Analysis ID: 240003019/PCBB-HN
Submission ID: 000.00.19.H26-241028-0026
Product Type: Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay)

Company information

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Product Owner: Nanjing Poclight Biotechnology Co., Ltd.
Authorized Representative: CÔNG TY TNHH Y TẾ VINDRAY

Technical details

Intended Use: Used to quantify Krebs von den Lungen 6 in human plasma. The test kit is used to support the diagnosis of the activity of interstitial pneumonia. For professional use and laboratory testing only.

Dates and status

Registration Date: Nov 04, 2024

About this record

Access comprehensive regulatory information for KL-6 Quantitative 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 240003019/PCBB-HN and manufactured by Nanjing Poclight Biotechnology Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ VINDRAY.

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