ONCOPROBE HIV 1&2 Antibody Rapid Test - Indonesia BPOM Medical Device Registration
ONCOPROBE HIV 1&2 Antibody Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305817111. The device is manufactured by FORMOSA BIOMEDICAL TECHNOLOGY CORP. from Taiwan (China), and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. MAIN ONCOPROBE.
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
FORMOSA BIOMEDICAL TECHNOLOGY CORP.Country of Origin
Taiwan (China)
Authorized Representative
PT. MAIN ONCOPROBEAR Address
APRT.ISTANA HARMONI LT.DASAR UNIT 1M, KOMP.HARMONI PLAZA JL.SURYOPRANOTO NO.2, PETOJO UTARA
Registration Date
Sep 18, 2021
Expiry Date
Sep 15, 2024
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
Invitro Diagnostics
ONCOPROBE HBsAg Rapid Test
FORMOSA BIOMEDICAL TECHNOLOGY CORP.
ONCOPROBE Methamphetamine Single Card
CAL-TECH DIAGNOSTICS, INC.
ONCOPROBE FOB + Transferrin Card Test
FORMOSA BIOMEDICAL TECHNOLOGY CORP.
ONCOPROBE Morphine Single Card
CAL-TECH DIAGNOSTICS, INC.
ONCOPROBE Rapid Multi Drug Cup 6 in 1 (AMP1000 ng/mL, BZD300ng/mL, COC300 ng/mL, MET500 ng/mL, MOR300 ng/mL, THC50 ng/mL)
CAL-TECH DIAGNOSTICS, INC.
ONCOPROBE Amphetamine single Card
CAL-TECH DIAGNOSTICS, INC.
TESHEAL+ Intestinal Mucosal Healing Gel
BI-TRUMED BIOTECH CO., LTD.
ONCOPROBE Benzodiazepine Single Card
CAL-TECH DIAGNOSTICS, INC.
ONCOPROBE THC Single Card
CAL-TECH DIAGNOSTICS, INC.
HUACHENG Disposable Surgical Active Electrodes (Electrosurgical Pencils)
JINHUA HUACHENG APPLIANCE CO., LTD.

