Zybio mALB Assay (Immunofluorescence) - Indonesia BPOM Medical Device Registration
Zybio mALB Assay (Immunofluorescence) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420410. The device is manufactured by PT 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
PT 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
Sep 10, 2024
Expiry Date
Jan 30, 2029
Product Type
Immunological Test System
Albumin immunological test system.
Invitro Diagnostics
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ZYBIO Glucose (GLU) Kit (Hexokinase Method)
Zybio Wash Solution
Zybio Cleanser
Zybio Nucleic Acid Extraction Kit for Bacteria (Magnetic Bead Method)
Zybio Nucleic Acid Extraction Kit for FFPE (Magnetic Bead Method)
Zybio Nucleic Acid Extraction Kit for Stool (Magnetic Bead Method)
Zybio Sheath Fluid
Zybio Urinalysis Diluent
ZYBIO EXZ 8000 Hematology Analyzer
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ZYBIO H58 LS Lyse
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ZYBIO H58 DN Diluent
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ZYBIO H58 LN Lyse
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ZYBIO H58 FD Dye
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Zybio PCT Control
PT ZYBIO INC.,
Zybio Cleanser
PT ZYBIO INC.,
Zybio Wash Solution
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Zybio Sheath Fluid
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Zybio SG Calibrator
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