ANSWER Malaria Pf/Pv Ag Rapid Test - Indonesia BPOM Medical Device Registration
ANSWER Malaria Pf/Pv Ag Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220691. The device is manufactured by BEIJING GENESEE BIOTECH INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is 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 : 2
Manufacturer
BEIJING GENESEE BIOTECH INC.Country of Origin
China
Authorized Representative
EXXEL MAINAR Address
JALAN RAJAWALI SELATAN.RUKO MULTI GUNA KEMAYORAN BLOK.6N.JAKARTA UTARA
Registration Date
Oct 12, 2022
Expiry Date
Oct 09, 2025
Product Type
Serological Reagents
Plasmodium species antigen detection assays
Invitro Diagnostics
ANSWER Dengue Ag Rapid Test
ANSWER HBsAg Rapid Test
ANSWER Malaria Pf/Pan Ag Rapid Test
ANSWER HAV IgG/IgM Rapid Test
ANSWER Syphilis Ab Rapid Test
ANSWER Leptospira IgG/IgM Combo Rapid Test Cassette
ANSWER HCV Ab Plus Rapid Test
ARIA Chlamydia Ag Rapid Test
ARIA Syphilis Ab Rapid Test
ARIA Leptospira IgG/IgM Combo Rapid Test
ANSWER Cocaine Urine Test Strip
ZHEJIANG ORIENT GENE BIOTECH CO.,LTD.
BIOAID Hemoglobin Testing System
HANGZHOU BOSURE BIOTECH CO., LTD
WONDFO Blood Gas Analyzer Test Card (pH/pCO2/pO2)
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO CK-MB Rapid Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
VERIFY Urinalyisis Reagent Strips 3PE (PRO, PH, GLU)
ACON BIOTECH (HANGZHOU) CO., LTD.
WONDFO T3 (Triidothyronine) Rapid Quantitative Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
WONDFO Microalbumin Rapid Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
WONDFO TSH (Thyroid-Stimulating Hormone) Rapid Quantitative Test
GUANGZHOU WONDFO BIOTECH CO., LTD.
VERIFY Urinalysis 10U Reagent Strips (LEU/NIT/URO/PRO/PH/BLO/SG/KET/BIL/GLU)
ACON BIOTECH (HANGZOU) CO.,LTD.
WONDFO fT4 Rapid Quantitative Test
GUANGZHOU WONDFO BIOTECH CO., LTD.

