Vietnam MOH registration 240003093/PCBB-HN

The IVD Base Complex: Total Bilirubin, Direct Bilirubin

VN: Cụm IVD chất nền: Bilirubin toàn phần, Bilirubin trực tiếp

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Zybio Inc.·Registered Nov 13, 2024

Registration details

Analysis ID: 240003093/PCBB-HN
Submission ID: 000.00.19.H26-241111-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Zybio Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Zybio Inc.
Authorized Representative: CÔNG TY TNHH KHOA HỌC P N D

Technical details

Intended Use: Total Bilirubin (TBIL) Kit (Vanadate Oxidation Method) (Product Code: 01.09.00.21.EC.01): In vitro test used to determine the concentration of total bilirubin in human clinical samples (serum or plasma). Clinically, the test is primarily used as a marker to evaluate disorders of bilirubin metabolism. Total Bilirubin (TBIL) Kit (Vanadate Oxidation Method) (Product Code: 01.09.00.21.EC.03): In vitro test used to determine the concentration of total bilirubin in human clinical samples (serum or plasma). Clinically, the test is primarily used as a marker to evaluate disorders of bilirubin metabolism. Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method) (Product Code: 01.09.00.20.EC.01): In vitro test used to determine the concentration of direct bilirubin in human clinical samples (serum or plasma). Clinically, the test is primarily used as a marker to evaluate disorders of bilirubin metabolism. Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method) (Product Code: 01.09.00.20.EC.02): In vitro test used to determine the concentration of direct bilirubin in human clinical samples (serum or plasma). Clinically, the test is primarily used as a marker to evaluate disorders of bilirubin metabolism.

Dates and status

Registration Date: Nov 13, 2024

About this record

Access comprehensive regulatory information for The IVD Base Complex: Total Bilirubin, Direct Bilirubin 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 240003093/PCBB-HN and manufactured by Zybio Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KHOA HỌC P N D.

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