Vietnam MOH registration 240001795/PCBB-HCM

IVD Enzyme Complex: Gamma; amylase; creatine kinase; alkaline phosphatase; Lactate dehydrogenase (LDH); SGOT; SGPT/ALT; lipase

VN: Cụm IVD Enzymes: Gamma; amylase; creatine kinase; alkaline phosphatase;Lactate dehydrogenase (LDH); SGOT; SGPT/ALT ; lipase
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Meril Diagnostics Pvt. Ltd·Registered Aug 14, 2024
Registration details
Analysis ID
240001795/PCBB-HCM
Submission ID
000.00.19.H29-240331-0003
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
Meril Diagnostics Pvt. Ltd
Authorized Representative
CÔNG TY TNHH MERIL (VIỆT NAM)
Technical details
Intended Use
Gamma GT Kit CliniQuant-FSR is used to quantitatively analyze Gamma GT in human serum. Amylase Kit CliniQuant-FSR is used to determine the concentration of amylase in human serum. Creatine Kinase Kit CliniQuant -FSR is used to determine the concentration of creatine kinase (CK) in human serum. Alkaline Phosphatase kit CliniQuant-FSR is used to determine the concentration of alkaline phosphatase in human serum. LDH-P Kit CliniQuant-FSR is used to determine the concentration of LDH in human serum. SGOT Kit CliniQuant-FSR is used to determine the concentration of SGOT in human serum. SGPT Kit CliniQuant-FSR is used to determine the concentration of SGPT/ALT in human serum. Lipase Kit CliniQuant -FSR is used to quantitatively analyze the concentration of pancreatic lipase in human serum. CK-MB Kit CliniQuant-FSR is used to determine the concentration of creatine kinase in human serum.
Dates and status
Registration Date
Aug 14, 2024
About this record

Access comprehensive regulatory information for IVD Enzyme Complex: Gamma; amylase; creatine kinase; alkaline phosphatase; Lactate dehydrogenase (LDH); SGOT; SGPT/ALT; lipase 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 240001795/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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