BERIGHT HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma) - Indonesia BPOM Medical Device Registration
BERIGHT HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305420653. The device is manufactured by HANGZHOU ALLTEST BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is RAJAERBA INDOCHEM.
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 : 3
Manufacturer
HANGZHOU ALLTEST BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
RAJAERBA INDOCHEMAR Address
Jl. Hj. Tutty Alawiyah No. 8, Desa/Kelurahan Duren Tiga, Kec. Pancoran, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12760
Registration Date
Jan 02, 2025
Expiry Date
Jan 10, 2029
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
Invitro Diagnostics
UNVEIL™ 25 OH Vitamin D (25-OH VD) Test Kit (CLIA)
UNVEIL ™ Procalcitonin (PCT) Test Kit (CLIA)
ALLCALL Uric Acid Test Strip
UNVEIL™ Glycated Hemoglobin (HbA1c) Test Kit (CLIA)
UNVEIL ™ Insulin (INS) Test Kit (CLIA)
UNVEIL ™ Serum Amyloid A Protein (SAA) Test Kit (CLIA)
OPTIMUS Test Syphilis Serum One Step Diagnostic Rapid Test (Cassette)
OPTIMUS Test Tuberculosis (TB) Serum One Step Diagnostic Rapid Test (Cassette)
ALLCALL Blood Glucose/Ketone/Uric Acid/Total Cholesterol 4 in 1 Monitoring System I
AIM Rapid Test Ferritin-F
COMBIWIDAL 'H' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
BERIGHT HCV Rapid Test Cassette (Whole Blood/Serum/Plasma)
HANGZHOU ALLTEST BIOTECH CO., LTD.
BERIGHT H. pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)
HANGZHOU ALLTEST BIOTECH CO., LTD.
COMBIWIDAL 'BO' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
COMBIWIDAL 'AO' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
COMBIWIDAL 'O' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
BERIGHT Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma)
HANGZHOU ALLTEST BIOTECH CO., LTD.
BERIGHT Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)
HANGZHOU ALLTEST BIOTECH CO., LTD.
LYSUN Multifunction Analysis Meter (Glucose, Uric Acid)
HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.
COMBIWIDAL 'CO' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.