FOCUS Hemolysis - Indonesia BPOM Medical Device Registration
FOCUS Hemolysis is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208020359. The device is manufactured by ZYBIO INC. 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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FOKUS Hemolyse
Risk Classification
Product Class
Kelas : 2
Manufacturer
ZYBIO INC.Country of Origin
China
Authorized Representative
PT. FOCUS DIAGNOSTIC INDONESIAAR Address
Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
Registration Date
Oct 26, 2022
Expiry Date
Oct 25, 2025
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
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ZYBIO EXZ 8000 Hematology Analyzer
ZYBIO H58 LS Lyse
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ZYBIO Hematology Control H5 Check (Normal Level)
ZYBIO Hematology Control H5 Check (High Level)
Zybio Hematology Control H5 Check (Low Level)
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