ANSWER Multi-Drug Rapid Test 7 Panel (AMP1000, MOP300, THC50, COC300, BZO300, MET1000, CAR2000) - Indonesia BPOM Medical Device Registration
ANSWER Multi-Drug Rapid Test 7 Panel (AMP1000, MOP300, THC50, COC300, BZO300, MET1000, CAR2000) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103420134. The device is manufactured by ACRO BIOTECH INC. from United States, and is classified as Risk Class Kelas Resiko : C. 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 : 2
Manufacturer
ACRO BIOTECH INC.Country of Origin
United States
Authorized Representative
PT. EXXEL MAINAR Address
JALAN RAJAWALI SELATAN.RUKO MULTI GUNA KEMAYORAN BLOK.6N.JAKARTA UTARA
Registration Date
Jun 04, 2024
Expiry Date
Jun 03, 2027
Product Type
Clinical Toxicology Test System
Multi parameter clinical toxicology test system
Invitro Diagnostics
DALF TUBERCULOSIS (TB) DROP TEST
ACRO HBsAB Rapid Test Cassette (Whole Blood/Serum/Plasma)
ACRO Multi-Drug 7 Drugs Rapid Test 1-Step Cup (Urine) (MDMA500/MET500/COC150/BZO200/AMP500/THC25/CAR2000)
ACRO Multi-Drug 10 Drugs Rapid Test 1-Step Cup (Urine) (OPI300/MDMA500/COC150/PCP25/MTD200/BZO200/AMP500/MET500/CAR2000/THC25)
ACRO HBsAb Rapid Test Dipstick (Whole blood/Whole Blood/Serum/Plasma)
HAV IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)
DALF FECAL OCCULT BLOOD DROP TEST
ACRO HbA1c Rapid Test Cassette (Whole Blood)
ACRO Multi-Drug 10 Drugs Rapid Test 2-Step Cup (Urine) (MOP300/MDMA500/COC300/THC50/AMP1000/MET1000 /MTD300/BAR300/BZO300/BUP10)
ACRO Multi-Drugs 10 Drugs Rapid Test Cassette (Oral Fluid) (OPI40/COC20/AMP50/PCP10)+(MET50/BZO30)+(MTD30/MDMA50)+CAR300+THC50
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