Vietnam MOH registration 240002995/PCBB-HN

The IVD Base Complex: Albumin, total protein, creatinine

VN: Cụm IVD chất nền: Albumin, protein toàn phần, creatinin

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Zybio Inc.·Registered Nov 01, 2024

Registration details

Analysis ID: 240002995/PCBB-HN
Submission ID: 000.00.19.H26-241030-0019
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: 1. Albumin (ALB) Kit (Bromocresol Green Method) (Product Code: 01.09.00.04.EC.01): In vitro test used to determine the concentration of albumin (ALB) in human blood samples. Clinically, the test is primarily used to support the evaluation of liver function as well as to assess nutritional status. 2. Albumin (ALB) Kit (Bromocresol Green Method) (Product Code: 01.09.00.04.EC.03): In vitro test used to determine the concentration of albumin (ALB) in human blood samples. Clinically, the test is primarily used to support the evaluation of liver function as well as to assess nutritional status. 3. Total Protein (TP) Kit (Biuret Method) (Product Code: 01.09.00.23.EC.01): In vitro test used to determine the concentration of total protein in human blood samples. Clinically, the test is primarily used to evaluate liver function. 4. Total Protein (TP) Kit (Biuret Method) (Product Code: 01.09.00.23.EC.02): In vitro test used to determine the concentration of total protein in human blood samples. Clinically, the test is primarily used to evaluate liver function. 5. Creatinine (CREA) Kit (Enzymatic Method) (Product Code: 01.09.01.05.EC.02): In vitro test used to determine the concentration of creatinine (CREA) in human blood, serum, or urine samples. Clinically, the test is primarily used as one of the indicators of kidney function. 6. Creatinine (CREA) Kit (Enzymatic Method) (Product Code: 01.09.01.05.EC.03): In vitro test used to determine the concentration of creatinine (CREA) in human blood, serum, or urine samples. Clinically, the test is primarily used as one of the indicators of kidney function.

Dates and status

Registration Date: Nov 01, 2024

About this record

Access comprehensive regulatory information for The IVD Base Complex: Albumin, total protein, creatinine 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 240002995/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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