ZYBIO EXZ 8000 Hematology Analyzer - Indonesia BPOM Medical Device Registration
ZYBIO EXZ 8000 Hematology Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205420251. The device is manufactured by ZYBIO INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ZYBIO MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ZYBIO INC.Country of Origin
China
Authorized Representative
ZYBIO MEDICAL INDONESIAAR Address
Satrio Tower Unit 8, Lantai 14 No. 5 Bok C4, Jl. Prof. Dr, Satrio No. 7, Kel. Setiabudi, Kec. Kuningan Timur, Kota Jakarta Selatan, Prov. DKI Jakarta
Registration Date
Nov 12, 2024
Expiry Date
Jan 30, 2029
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated differential cell counter.
Invitro Diagnostics
ZYBIO FT4 Assay (Immunofluorescence)
ZYBIO Urinalysis Hybrid System Series U3601
ZYBIO H58 LS Lyse
ZYBIO H58 LD Lyse
ZYBIO H58 LN Lyse
ZYBIO H58 FR Dye
ZYBIO Hematology Control H5 Check (High Level)
Zybio Hematology Control H5 Check (Low Level)
ZYBIO Hematology Control H5 Check (Normal Level)
ZYBIO Human Papillomavirus qPCR Detection Kit (PCRFluorescence Probing Method)
ZYBIO H58 LS Lyse
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ZYBIO H58 LN Lyse
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ZYBIO H58 DN Diluent
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ZYBIO H58 FD Dye
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Zybio mALB Assay (Immunofluorescence)
PT ZYBIO INC.,
Zybio PCT Control
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Zybio Cleanser
PT ZYBIO INC.,
Zybio Wash Solution
PT ZYBIO INC.,
Zybio Sheath Fluid
PT ZYBIO INC.,
Zybio Turbidity Calibrator
PT ZYBIO INC.,