MAGLUMI™ Total PSA (CLIA) - Indonesia BPOM Medical Device Registration
MAGLUMI™ Total PSA (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306911342. The device is manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is MULTIMEDILAB KARYAMANDIRI.
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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
Dec 19, 2022
Expiry Date
Dec 31, 2025
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
MAGLUMI HAV IgM (CLIA)
MAGLUMI Toxo IgG (CLIA)
MAGLUMI Rubella IgM (CLIA)
MAGLUMI CMV IgM (CLIA)
MAGLUMI™ Estradiol (CLIA)
MAGLUMI™ Ferritin (CLIA)
MAGLUMI™ T4 (CLIA)
MAGLUMI 4000 CLIA Analyzer and Accessories
Maglumi™ Light Check
MAGLUMI 800 CLIA Analyzer and Accessories
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 ® TRAb (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., 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.