Vietnam MOH registration 240001801/PCBB-HCM

IVD Enzyme Complex: Gamma; amylase; creatine kinase; lipase; alkaline phosphatase; SGOT; SGPT/ALT

VN: Cụm IVD Enzymes: Gamma; amylase; creatine kinase; lipase; alkaline phosphatase; SGOT; SGPT/ALT

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Meril Diagnostics Pvt. Ltd·Registered Aug 14, 2024

Registration details

Analysis ID: 240001801/PCBB-HCM
Submission ID: 000.00.19.H29-240316-0004
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

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)

Technical details

Intended Use: Gamma GT Kit AutoQuant is used to quantitatively analyze Gamma GT in human serum on the AutoQuant 400i/ 400 Supremus/ 400. Amylase Kit AutoQuant is used to determine the quantitative amount of amylase in human serum on the AutoQuant 400i/ 400 Supremus/ 400. Creatine Kinase Kit AutoQuant is used to determine the quantitative amount of creatine kinase (CK) in human serum on the AutoQuant 400i/ 400 Supremus/ 400. Lipase Kit AutoQuant is used to quantitatively analyze the amount of lipase in human serum on the AutoQuant 400i/ 400 Supremus/ 400. Alkaline Phosphatase kit AutoQuant is used to determine the quantitative amount of alkaline phosphatase in human serum on the AutoQuant 400i/ 400 Supremus/ 400. LDH-P Kit AutoQuant is used to determine the quantitative amount of lactate dehydrogenase in human serum on the AutoQuant 400i/ 400 Supremus/ 400. CK-MB Kit AutoQuant is used to determine the quantitative amount of creatine kinase in human serum on the AutoQuant 400i/ 400 Supremus/ 400. SGOT Kit AutoQuant is used to determine the quantitative amount of SGOT in human serum on the AutoQuant 400i/ 400 Supremus/ 400. SGPT Kit AutoQuant is used to determine the quantitative amount of SGPT/ALT in human serum on the AutoQuant 400i/ 400 Supremus/ 400.

Dates and status

Registration Date: Aug 14, 2024

About this record

Access comprehensive regulatory information for IVD Enzyme Complex: Gamma; amylase; creatine kinase; lipase; alkaline phosphatase; 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 240001801/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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