MAGLUMI Digoxin (CLIA) - Indonesia BPOM Medical Device Registration
MAGLUMI Digoxin (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103420304. The device is manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SNIBE DIAGNOSTIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Country of Origin
China
Authorized Representative
PT. SNIBE DIAGNOSTIC INDONESIAAR Address
TEMPO SCAN TOWER, LANTAI 21, JALAN H.R. RASUNA SAID KAV. 3-4
Registration Date
Nov 06, 2024
Expiry Date
Aug 16, 2029
Product Type
Clinical Toxicology Test System
Digoxin test system (kit & cair)
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BIOSSAYS Alkaline phospatase Assay Kit (IFCC)
BIOSSAYSโข ALT Alanine Aminotransferase Assay Kit (IFCC)
MOLECISIONโข SARS-CoV-2 RT-PCR Assay
MOLECISIONโข Nucleic Acid Extraction Kit
Laboratory Automation System SATLARSโข T8
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI Osteocalcin (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI EPO (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI ICA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI Anti-Cardiolipin IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI Anti-Cardiolipin (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI Anti-Cardiolipin IgM (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI Anti-ฮฒ2-Glycoprotein 1 IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI Anti-ฮฒ2-Glycoprotein 1 IgM (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI Anti-Cardiolipin IgA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.

