ANSWER HIV 1/2/O Tri line Rapid Test Cassette (Serum/Plasma /Whole Blood) - Indonesia BPOM Medical Device Registration
ANSWER HIV 1/2/O Tri line Rapid Test Cassette (Serum/Plasma /Whole Blood) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305321228. The device is manufactured by ACON BIOTECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. EXXEL MAIN.
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
ACON BIOTECH (HANGZHOU) CO., LTD.Country of Origin
China
Authorized Representative
PT. EXXEL MAINAR Address
JALAN RAJAWALI SELATAN.RUKO MULTI GUNA KEMAYORAN BLOK.6N.JAKARTA UTARA
Registration Date
Nov 18, 2023
Expiry Date
Jan 25, 2026
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
Invitro Diagnostics
ACON HBsAg Rapid Test Strip
PROMOTOR HPV 18 High-Risk Types with 16/18 Genotyping Test Kit
INSIGHT Expert U500 Urine Analyzer and Accessories
MINDRAY U-11 Urine Test Strips
INSIGHT Expert Urinalysis Reagent Strips
PROMOTOR Nucleic Acid Extraction Kit
ON CALL Blood Uric Acid Test Strips
ON CALL Blood Ketone Test Strips
VERIFY™ Liquid Urine Control
ON-CALL GK Dual Blood Glucose & Ketone Meter
WONDFO cTnI/CK-MB/Myo Multi-Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO T3/T4/TSH Multi-Control
GUANGZHOU WONDFO BIOTECH CO., LTD
ANSWER HCG Urine Test Strip
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO Coagulation Control
GUANGZHOU WONDFO BIOTECH CO., LTD.
ANSWER HCG Urine Test Cassette
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO MAU Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO CRP Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO HbA1c Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO FIA Meter III Plus
GUANGZHOU WONDFO BIOTECH CO., LTD
ANSWER Diagnostic Kit for IgM Antibody to Hepatitis A Virus (Colloidal Gold)
GUANGZHOU WONDFO BIOTECH CO., LTD