Vietnam MOH registration 240002884/PCBB-HN

Quantitative Testing Calibration Standard 31 Biochemical Parameters

VN: Chất hiệu chuẩn xét nghiệm định lượng 31 thông số sinh hóa

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Zybio Inc.·Registered Oct 25, 2024

Registration details

Analysis ID: 240002884/PCBB-HN
Submission ID: 000.00.19.H26-241010-0030
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: Products suitable for calibrating the 31 enzymatic assays of Zybio Inc. (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, cholinesterase, total cholesterol, creatine kinase, carbon dioxide, creatinine, direct bilirubin, ferrum, γ-glutamyl transferase, glutamate dehydrogenase, glucose, lactate, leucine amino peptidase, lactate dehydrogenase, lipase, magnesium, inorganic phosphorus, total bile acid, total bilirubin, triglyceride, total protein, uric acid, urea, zinc, α-amylase, α-hydroxybutyrate dehydrogenase and β-hydroxybutyrate).

Dates and status

Registration Date: Oct 25, 2024

About this record

Access comprehensive regulatory information for Quantitative Testing Calibration Standard 31 Biochemical Parameters 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 240002884/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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