BIOASSAYS Direct bilirubin Assay Kit (Vanadate) - Indonesia BPOM Medical Device Registration
BIOASSAYS Direct bilirubin Assay Kit (Vanadate) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101816186. 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. MULTI SYNERGY ANUGRAH SEJAHTERA.
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Risk Classification
Product Class
Kelas : 2
Country of Origin
China
Authorized Representative
PT. MULTI SYNERGY ANUGRAH SEJAHTERAAR Address
JL. Wonodri Sendang Raya No. 10, RT 4 / RW 5 Kel. Wonodri Kec. Semarang Selatan
Registration Date
Dec 13, 2023
Expiry Date
Dec 31, 2025
Product Type
Clinical Chemistry Test System
Bilirubin (total or direct) test system (kit & cair)
Invitro Diagnostics
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MAGLUMI Anti-Cardiolipin IgM (CLIA)
MAGLUMI Anti-Cardiolipin (CLIA)
MAGLUMI Anti-Cardiolipin IgG (CLIA)
MAGLUMI Anti-ฮฒ2-Glycoprotein 1 IgM (CLIA)
MAGLUMI Anti-ฮฒ2-Glycoprotein 1 IgG (CLIA)
MAGLUMI Anti-Cardiolipin IgA (CLIA)
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