ZYBIO T4 Assay (CLIA) - Indonesia BPOM Medical Device Registration
ZYBIO T4 Assay (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221525. 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. ZYBIO MEDICAL INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ZYBIO INC.Country of Origin
China
Authorized Representative
PT. 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
Sep 21, 2022
Expiry Date
Jan 03, 2027
Product Type
Clinical Chemistry Test System
Total triiodothyronine test system (kit & cair)
Invitro Diagnostics
ZYBIO FT4 Assay (Immunofluorescence)
ZYBIO Urinalysis Hybrid System Series U3601
ZYBIO EXZ 8000 Hematology Analyzer
ZYBIO H58 LS Lyse
ZYBIO H58 LN Lyse
ZYBIO H58 LD Lyse
ZYBIO H58 FR Dye
ZYBIO Hematology Control H5 Check (Normal Level)
ZYBIO Hematology Control H5 Check (High Level)
Zybio Hematology Control H5 Check (Low Level)
ZYBIO FT4 Assay (Immunofluorescence)
ZYBIO INC.
ZYBIO Urinalysis Hybrid System Series U3601
ZYBIO INC.
ZYBIO H58 LD Lyse
ZYBIO INC.
ZYBIO H58 DR Diluent
ZYBIO INC.,
ZYBIO H58 FN Dye
ZYBIO INC
ZYBIO H58 FR Dye
ZYBIO INC.
Zybio Automated Blood Coagulation Analyzer YX-3000
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.
Zybio Automated Blood Coagulation Analyzer YX-2000
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.
Zybio Antithrombin III Reagent Kit (Chromogenic Substrate Method)
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.
Zybio Blood Coagulation Unassayed Controls
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.