MAGLUMI ® TRAb (CLIA) - Indonesia BPOM Medical Device Registration
MAGLUMI ® TRAb (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420305. 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 MULTIMEDILAB KARYAMANDIRI.
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MAGLUMI ® TRAb (CLIA)
Risk Classification
Product Class
Kelas : 2
Country of Origin
China
Authorized Representative
MULTIMEDILAB KARYAMANDIRIAR Address
GP plaza lantai 3 unit 6, jalan Gelora II No. 01
Registration Date
Jul 03, 2024
Expiry Date
Dec 31, 2025
Product Type
Immunological Test System
Thyroid autoantibody immunological test system.
Invitro Diagnostics
Laboratory Automation System SATLARS™ T8
MAGLUMI EPO (CLIA)
MAGLUMI Osteocalcin (CLIA)
MAGLUMI ICA (CLIA)
MAGLUMI Anti-Cardiolipin IgM (CLIA)
MAGLUMI Anti-Cardiolipin (CLIA)
MAGLUMI Anti-Cardiolipin IgG (CLIA)
MAGLUMI Anti-β2-Glycoprotein 1 IgM (CLIA)
MAGLUMI Anti-β2-Glycoprotein 1 IgG (CLIA)
MAGLUMI Anti-Cardiolipin IgA (CLIA)
AGAPPE Albumin Mispa CCXL, CXLpro, CX4
AGAPPE DIAGNOSTICS SWITZERLAND GMBH.
MAGLUMI ® HBsAg (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI ® ON SCREEN (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI ® Total T4 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
Agappe HDL-C DIRECTCCXL,CXLpro,CX4
AGAPPE DIAGNOSTICS LTD.
AGAPPE ENZYMATIC CREATININE CCXL,CXLpro,CX4
AGAPPE DIAGNOSTICS LTD.
MAGLUMI ® Total β HCG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
AGAPPE GLUCOSE MISPA CCXL
AGAPPE DIAGNOSTICS LTD.
AGAPPE SGPT CCXL,CXLpro,CX4
AGAPPE DIAGNOSTICS LTD.
AGAPPE SGOT MISPA CCXL
AGAPPE DIAGNOSTICS LTD.

