FOKUS Creatinine (Enzyme) - Indonesia BPOM Medical Device Registration
FOKUS Creatinine (Enzyme) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221090. The device is manufactured by SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTDCountry of Origin
China
Authorized Representative
PT. FOCUS DIAGNOSTIC INDONESIAAR Address
18 Office Park, Tower A, Jl. TB Simatupang No.18 MZ Floor, Unit D1-A/89, Kelurahan Kebagusan
Registration Date
Jul 27, 2022
Expiry Date
Jul 26, 2025
Product Type
Clinical Chemistry Test System
Creatinine test system (kit & cair)
Invitro Diagnostics
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FOKUS Creatinine Kinase-MB (CK-MB/Selective Inhibition)
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FOKUS Low Density Lipoprotein Cholesterol (LDL-C/Direct)
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FOKUS Glutamate Pyruvate Transaminase (ALT/IFCC)
FOKUS Glutamate Oxaloacetate Transaminase (AST/IFCC)
FOCUS Total Bilirubin (TBil)/VOX)
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FOCUS Leptospira IgM Cassette
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FOKUS FDI HM-5 Plus Diluent Hematology Reagent
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FOKUS Love-Gruenwald Laminectomy Rongeur Instrument
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FOKUS Measuring Instrument Set II
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