Zybio PCT Control - Indonesia BPOM Medical Device Registration
Zybio PCT Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421065. 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
Jun 04, 2024
Expiry Date
Jan 30, 2028
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
Zybio mALB Assay (Immunofluorescence)
ZYBIO Calcium (Ca) Kit (Arsenazo III Method)
ZYBIO Glucose (GLU) Kit (Hexokinase Method)
Zybio Cleanser
Zybio Wash Solution
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 Urinalysis Diluent
Zybio Sheath Fluid
ZYBIO EXZ 8000 Hematology Analyzer
ZYBIO INC.
ZYBIO H58 LS Lyse
ZYBIO INC.
ZYBIO H58 DN Diluent
ZYBIO INC.,
ZYBIO H58 LN Lyse
ZYBIO INC.
ZYBIO H58 FD Dye
ZYBIO INC.,
Zybio mALB Assay (Immunofluorescence)
PT ZYBIO INC.,
Zybio Cleanser
PT ZYBIO INC.,
Zybio Wash Solution
PT ZYBIO INC.,
Zybio Sheath Fluid
PT ZYBIO INC.,
Zybio Turbidity Calibrator
PT ZYBIO INC.,

