QUANTILAB Direct Bilirubin - Indonesia BPOM Medical Device Registration
QUANTILAB Direct Bilirubin is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101120576. The device is manufactured by INSTRUMENTATION LABORATORY SPA, from Italy, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DEXA ARFINDO PRATAMA.
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
INSTRUMENTATION LABORATORY SPA,Country of Origin
Italy
Authorized Representative
PT. DEXA ARFINDO PRATAMAAR Address
Raya jemursari 203/C-16 RT 003 RW 007, Sidosermo Wonocolo-Surabaya
Registration Date
Jan 27, 2021
Expiry Date
Dec 31, 2024
Product Type
Clinical Chemistry Test System
Bilirubin (total or direct) test system (kit & cair)
Invitro Diagnostics
QUANTILAB Phosphorus
QUANTILAB AST/GOT Liquid
QUANTILAB TOTAL PROTEIN
QUANTILAB Magnesium
QUANTILAB Uric Acid
QUANTILAB ReferrIL G Diluent
QUANTILAB Total Bilirubin
QUANTILAB ReferrIL HDL-LDL
QUANTILAB AMYLASE
QUANTILAB Triglycerides
QUANTILAB Phosphorus
INSTRUMENTATION LABORATORY SPA,
QUANTILAB AST/GOT Liquid
INSTRUMENTATION LABORATORY SPA,
QUANTILAB TOTAL PROTEIN
INSTRUMENTATION LABORATORY SPA,
QUANTILAB Iron
INSTRUMENTATION LABORATORY SPA.
QUANTILAB Magnesium
INSTRUMENTATION LABORATORY SPA,
QUANTILAB TIBC
INSTRUMENTATION LABORATORY SPA.
QUANTILAB Uric Acid
INSTRUMENTATION LABORATORY SPA,
QUANTILAB ReferrIL G Diluent
INSTRUMENTATION LABORATORY SPA,
QUANTILAB Cholesterol
INSTRUMENTATION LABORATORY SPA.
QUANTILAB ฮณ-GT Liquid
INSTRUMENTATION LABORATORY SPA.