m-PIMA™ HIV-1/2 VL - Indonesia BPOM Medical Device Registration
m-PIMA™ HIV-1/2 VL is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305120011. The device is manufactured by ABBOTT RAPID DIAGNOSTICS JENA GMBH from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ALERE HEALTH.
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
ABBOTT RAPID DIAGNOSTICS JENA GMBHCountry of Origin
Germany
Authorized Representative
ALERE HEALTHAR Address
K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan
Registration Date
Feb 05, 2025
Expiry Date
Jan 15, 2029
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
Invitro Diagnostics
DETERMINE™ HIV Controls
ABBOTT DIAGNOSTICS MEDICAL CO., LTD
DETERMINE™ Chase Buffer
ABON BIOPHARM (HANGZHOU) CO., LTD.
Panbio™ COVID-19/Flu A&B Panel (Nasal)
ABBOTT DIAGNOSTICS KOREA INC.
Afinion™ HbA1c Control
AXIS-SHIELD DIAGNOSTICS, LTD
ABON™ URINE TEST DRUG SCREEN STRIP (MET 1000)
ABON BIOPHARM (HANGZHOU) CO., LTD
ABON™ URINE TEST DRUG SCREEN STRIP (AMP 1000)
ABON BIOPHARM (HANGZHOU) CO., LTD
ABON™ URINE TEST DRUG SCREEN STRIP (MDMA 500)
ABON BIOPHARM (HANGZHOU) CO., LTD
ABON™ URINE TEST DRUG SCREEN STRIP (BZO 300)
ABON BIOPHARM (HANGZHOU) CO., LTD
ABON ™ URINE TEST DRUG SCREEN CASSETTE (COC 300)
ABON BIOPHARM (HANGZHOU) CO., LTD
ABON™ URINE TEST DRUG SCREEN CASSETTE (MOP 300)
ABON BIOPHARM (HANGZHOU) CO., LTD

