FOKUS Glutamate Pyruvate Transaminase (ALT/IFCC) - Indonesia BPOM Medical Device Registration
FOKUS Glutamate Pyruvate Transaminase (ALT/IFCC) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221046. The device is manufactured by SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC 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
SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTDCountry of Origin
China
Authorized Representative
PT. FOCUS DIAGNOSTIC INDONESIAAR Address
18 Office Park, Tower A, Jl. TB Simatupang No.18 MZ Floor, Unit D1-A/89, Kelurahan Kebagusan
Registration Date
Jul 18, 2022
Expiry Date
Apr 14, 2024
Product Type
Clinical Chemistry Test System
Alanine amino transferase (ALT/SGPT) test system (kit & cair)
Invitro Diagnostics
FOCUS DS5 Semi - Auto Chemistry Analyzer
FOKUS DS7 Fully Auto Chemistry Analyzer
FOKUS ฮฑ -Amylase (AMY/Enzymatic)
FOKUS Creatinine Kinase-MB (CK-MB/Selective Inhibition)
FOCUS Lipase (LPS/Methyl halogen test)
FOKUS Low Density Lipoprotein Cholesterol (LDL-C/Direct)
FOKUS Total Cholesterol (CHO/CHOD-PAP)
FOKUS Creatinine (Enzyme)
FOKUS Glutamate Oxaloacetate Transaminase (AST/IFCC)
FOKUS Urea (Enzymatic)
FOKUS FDI HM-3 Plus Diluent Hematology Reagent
AEHEALTH LIMITED
FlowClean Cleaning Agent
BECKMAN COULTER, INC.
FOKUS Auto 3-Diff Hematology Analyzer
AEHEALTH LIMITED
AQUIOS Cleaning Agent
BECKMAN COULTER, INC.
FOKUS FDI HM-5 Plus DIFF Lyse Hematology Reagent
AEHEALTH LIMITED
FOCUS Leptospira IgM Cassette
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS FDI HM-5 Plus Diluent Hematology Reagent
AEHEALTH LIMITED
FOCUS Syphicheck WB device
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS Love-Gruenwald Laminectomy Rongeur Instrument
CEATEC MEDIZINTECHNIK GMBH & CO. KG.
FOKUS Measuring Instrument Set II
CEATEC MEDIZINTECHNIK GMBH