IVD Enzyme Complex: Gamma; amylase; creatine kinase; alkaline phosphatase; Lactate dehydrogenase; lipase; SGOT; SGPT/ALT
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Meril Diagnostics Pvt. Ltd·Registered Aug 14, 2024- Analysis ID
- 240001793/PCBB-HCM
- Submission ID
- 000.00.19.H29-240322-0022
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Meril Diagnostics Pvt. Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Meril Diagnostics Pvt. Ltd
- Authorized Representative
- CÔNG TY TNHH MERIL (VIỆT NAM)
- Intended Use
- Gamma GT Kit AutoQuant is used to quantitatively analyze Gamma GT in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer. Amylase Kit AutoQuant is used to determine the quantitative concentration of amylase in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer. Creatine Kinase Kit AutoQuant is used to determine the quantitative concentration of creatine kinase (CK) in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer. Alkaline Phosphatase kit AutoQuant is used to determine the quantitative concentration of alkaline phosphatase in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer. LDH-P Kit AutoQuant is used to determine the quantitative concentration of lactate dehydrogenase (LDH) in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer. SGOT Kit AutoQuant is used to determine the quantitative concentration of SGOT in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer. Lipase Kit AutoQuant is used to quantitatively analyze the concentration of pancreatic lipase in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer. CK-MB Kit AutoQuant is used to determine the quantitative concentration of creatine kinase in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer. SGPT Kit AutoQuant is used to determine the quantitative concentration of SGPT/ALT in human serum on the AutoQuant 100/ 100 Amara/200i/200 Excelus biochemical analyzer.
- Registration Date
- Aug 14, 2024
Access comprehensive regulatory information for IVD Enzyme Complex: Gamma; amylase; creatine kinase; alkaline phosphatase; Lactate dehydrogenase; lipase; SGOT; SGPT/ALT 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 240001793/PCBB-HCM and manufactured by Meril Diagnostics Pvt. Ltd. The authorized representative in Vietnam is CÔNG TY TNHH MERIL (VIỆT NAM).
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