Zybio SG Calibrator - Indonesia BPOM Medical Device Registration
Zybio SG Calibrator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101322445. 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
MGK office tower B, lantai 8, Unit 8B, Jl, Angkasa Kavling B-6, Kota Adm, Jakarta Pusat, Provinsi DKI Jakarta 10610
Registration Date
Jan 25, 2023
Expiry Date
Jan 03, 2027
Product Type
Clinical Chemistry Test System
Calibrator (cair)
Invitro Diagnostics
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Zybio PCT Control
ZYBIO Calcium (Ca) Kit (Arsenazo III Method)
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 EXZ 8000 Hematology Analyzer
ZYBIO INC.
ZYBIO H58 LS Lyse
ZYBIO INC.
ZYBIO H58 LN Lyse
ZYBIO INC.
ZYBIO H58 DN Diluent
ZYBIO INC.,
ZYBIO H58 FD Dye
ZYBIO INC.,
Zybio mALB Assay (Immunofluorescence)
PT ZYBIO INC.,
Zybio PCT Control
PT ZYBIO INC.,
Zybio Cleanser
PT ZYBIO INC.,
Zybio Wash Solution
PT ZYBIO INC.,
Zybio Sheath Fluid
PT ZYBIO INC.,