Vietnam MOH registration 240000013/PCBB-HP
IVD Base Compound
VN: Cụm IVD Chất nền
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Shanghai Kehua Bio-Engineering Co., Ltd.·Registered Aug 26, 2024Registration details
- Analysis ID
- 240000013/PCBB-HP
- Submission ID
- 000.00.18.H24-240802-0003
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Shanghai Kehua Bio-Engineering Co., Ltd.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Shanghai Kehua Bio-Engineering Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH CÔNG NGHỆ TIANLONG VIỆT NAM
Technical details
- Intended Use
- Total Cholesterol Kit (CHOD-PAP Method) is an in vitro diagnostic test used to measure total cholesterol in serum, Heparin plasma, or EDTA plasma on a clinical chemistry analyzer, for use as a diagnostic aid. Triglycerides Kit (GPO-PAP Method) is an in vitro diagnostic test used to measure triglycerides in human serum, Heparin plasma, or EDTA plasma on a clinical chemistry analyzer, for use as a diagnostic aid. Total Protein Kit (Biuret Method) is an in vitro diagnostic test used to measure total protein in human serum, Heparin plasma, or EDTA plasma on a clinical chemistry analyzer, for use as a diagnostic aid. High Density Lipoprotein Cholesterol Kit (Enzyme Clearance Assay) is an in vitro diagnostic test used to measure HDL-cholesterol in human serum on a clinical chemistry analyzer (Enzyme Clearance Assay) for use as a clinical diagnostic aid. Low Density Lipoprotein Cholesterol Kit (Enzyme Clearance Assay) is an in vitro diagnostic test used to measure low density lipoprotein cholesterol in human serum on a clinical chemistry analyzer (Immuno Turbidimetric Assay) for use as a clinical diagnostic aid. Glucose Kit (HK Method) is an in vitro diagnostic test used to measure glucose (GLU) in human serum and Heparin plasma on a clinical chemistry analyzer. Glucose Kit (GOD-PAP Method) is an in vitro diagnostic test used to measure glucose (GLU) in human serum on a clinical chemistry analyzer for use as a diagnostic aid. Direct Bilirubin Kit (Vanadate Oxidation Method) is an in vitro diagnostic test used to measure direct bilirubin in human serum and Heparin plasma on a clinical chemistry analyzer for use as a diagnostic aid. Total Bilirubin Kit (Vanadate Oxidation Method) is an in vitro diagnostic test used to measure total bilirubin in human serum or Heparin plasma on a clinical chemistry analyzer for use as a diagnostic aid. Uric Acid Kit (Uricase-PAP Method) is an in vitro diagnostic test used to measure uric acid in human serum, Heparin plasma, and urine on a clinical chemistry analyzer for use as a diagnostic aid. UREA Kit (UV-GLDH Method) is an in vitro diagnostic test used to measure urea in human serum, Heparin plasma, or EDTA plasma and urine on a clinical chemistry analyzer for use as a clinical diagnostic aid. Creatinine Kit (Sarcosine Oxidase - PAP Method) is an in vitro diagnostic test used to measure creatinine in human serum, Heparin plasma, or EDTA plasma and urine on a clinical chemistry analyzer for use as a diagnostic aid. Albumin Kit (Bromocresol Green Method) is an in vitro diagnostic test for the measurement of albumin in human serum, Heparin plasma, or EDTA plasma on a clinical chemistry analyzer. Hemoglobin A1c Assay Kit (Latex Immunoturbidimetric Method) is an in vitro diagnostic test used to determine the concentration of hemoglobin A1c (HbA1c) in whole blood to support clinical diagnostic aid. Creatine Kinase (NAC Method) is an in vitro diagnostic test used to measure creatine kinase in human serum or Heparin plasma on a clinical chemistry analyzer for use as a clinical
Dates and status
- Registration Date
- Aug 26, 2024
Companies making similar products
Companies providing products similar to "IVD Base Compound"
Recent registrations
Recently registered similar products
The IVD Base Compound Cluster: Glucose (GLU), Uric Acid (UA), Urea (UREA), Total Bilirubin (TBIL), Direct Bilirubin (DBIL), Albumin (ALB)Oct 28, 2024
Manufacturer: Zybio Inc.
Registration: 240002912/PCBB-HN
IVD Base CompoundJun 30, 2023
Manufacturer: Theo theo phụ lục
Registration: 230001481/PCBB-HN
IVD Base Compound: CreatinineNov 24, 2022
Manufacturer: Theo theo phụ lục
Registration: 220003457/PCBB-BYT
About this record
Access comprehensive regulatory information for IVD Base Compound in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000013/PCBB-HP and manufactured by Shanghai Kehua Bio-Engineering Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH CÔNG NGHỆ TIANLONG VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, Zybio Inc., and 3 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
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