BIOTIME TSH Rapid Quantitative Test (Chemiluminescence Immunoassay) - Indonesia BPOM Medical Device Registration
BIOTIME TSH Rapid Quantitative Test (Chemiluminescence Immunoassay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101422514. The device is manufactured by XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GOLDEN MEDIKA MANDIRI.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. GOLDEN MEDIKA MANDIRIAR Address
Jl. Raya Kalirungkut 27 Blok C-65
Registration Date
Dec 12, 2024
Expiry Date
Jan 04, 2029
Product Type
Clinical Chemistry Test System
Thyroid stimulating hormone test system (kit & cair)
Invitro Diagnostics
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BIOTIME TSH Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME HbA1c Rapid Quantitative Test
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BIOTIME TT4 Rapid Quantitative Test
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BIOTIME MAU Rapid Quantitative Test
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BIOTIME TT3 Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME FIA Analyzer FLI-100
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME Dengue IgG/IgM Rapid Test
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BIOTIME Dengue NS1 Antigen Rapid Test
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