ZYBIO Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method) - Indonesia BPOM Medical Device Registration
ZYBIO Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324631. 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
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
Dec 27, 2023
Expiry Date
Jan 30, 2028
Product Type
Clinical Chemistry Test System
Bilirubin (total or direct) test system (kit & cair)
Invitro Diagnostics
ZYBIO H58 DN Diluent
ZYBIO H58 DR Diluent
ZYBIO H58 FD Dye
ZYBIO C-Reactive Protein/Serum Amyloid A Control
ZYBIO Lactate Dehydrogenase (LDH) Kit (Rate Method)
ZYBIO Triglyceride (TG) Kit (Enzymatic Method)
ZYBIO Gamma-Glutamyl Transferase (GGT) Kit (Enzymatic Method)
ZYBIO Alkaline Phosphatase (ALP) Kit (Enzymatic Method)
ZYBIO Urea (UREA) Kit (Urease-GLDH Method)
ZYBIO Alanine Aminotransferase (ALT) Kit (Enzymatic Method)
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.