ZYBIO PCT Assay (CLIA) - Indonesia BPOM Medical Device Registration
ZYBIO PCT Assay (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220746. 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
Oct 31, 2022
Expiry Date
Jan 13, 2027
Product Type
Serological Reagents
Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis
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 Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method)
ZYBIO Gamma-Glutamyl Transferase (GGT) Kit (Enzymatic Method)
ZYBIO Alkaline Phosphatase (ALP) Kit (Enzymatic Method)
ZYBIO Urea (UREA) Kit (Urease-GLDH 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.