The IVD Base Compound Cluster: Glucose (GLU), Uric Acid (UA), Urea (UREA), Total Bilirubin (TBIL), Direct Bilirubin (DBIL), Albumin (ALB)
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Zybio Inc.·Registered Oct 28, 2024- Analysis ID
- 240002912/PCBB-HN
- Submission ID
- 000.00.19.H26-241024-0007
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Zybio Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Zybio Inc.
- Authorized Representative
- CÔNG TY TNHH AVANTA DIAGNOSTICS
- Intended Use
- Glucose (GLU) Kit (Hexokinase Method): In vitro test to determine the concentration of glucose in serum or plasma samples from humans. Clinically, the test is used to diagnose diabetes; Uric Acid (UA) Kit (Uricase Method): In vitro test to determine the concentration of uric acid in serum or plasma samples from humans. Clinically, the test is primarily used as a supportive diagnostic tool for hyperuricemia; Urea (UREA) Kit (Urease-GLDH Method): In vitro test to determine the concentration of urea in serum or plasma samples from humans. Clinically, the test is primarily used as one of the indicators of kidney function; Total Bilirubin (TBIL) Kit (Vanadate-Oxidation Method): In vitro test to determine the concentration of total bilirubin in serum or plasma samples from humans. Clinically, the test is primarily used as one of the indicators of bilirubin metabolism disorders; Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method): In vitro test to determine the concentration of direct bilirubin in serum or plasma samples from humans. Clinically, the test is primarily used as an indicator of disorders in bilirubin metabolism; Albumin (ALB) Kit (Bromocresol Green Method): In vitro test to determine the concentration of albumin in serum samples from humans. Clinically, the test is primarily used as a tool to assess liver function as well as nutritional status.
- Registration Date
- Oct 28, 2024
Access comprehensive regulatory information for The IVD Base Compound Cluster: Glucose (GLU), Uric Acid (UA), Urea (UREA), Total Bilirubin (TBIL), Direct Bilirubin (DBIL), Albumin (ALB) 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 240002912/PCBB-HN and manufactured by Zybio Inc.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.
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