DETERMINE HBsAg 2 - Indonesia BPOM Medical Device Registration
DETERMINE HBsAg 2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305123696. The device is manufactured by ABBOTT DIAGNOSTICS MEDICAL CO., LTD. from Japan, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. 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 : 3
Manufacturer
ABBOTT DIAGNOSTICS MEDICAL CO., LTD.Country of Origin
Japan
Authorized Representative
PT. 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 06, 2025
Expiry Date
Jun 04, 2027
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
Invitro Diagnostics
Biolineโข HCV
ABBOTT DIAGNOSTICS KOREA INC
BIOLINE Salmonella Typhi IgG/IgM Fast
ABBOTT DIAGNOSTICS KOREA INC
AFINIONโข Lipid Panel Control
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
DETERMINEโข HIV Early Detect
ABBOTT DIAGNOSTICS MEDICAL CO., LTD
BIOLINEโข Dengue NS1 Ag
ABBOTT DIAGNOSTICS KOREA INC
AFINIONโข Lipid Panel
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
BIOLINEโข Rotavirus
ABBOTT DIAGNOSTICS KOREA INC
BIOLINEโข Dengue Duo
ABBOTT DIAGNOSTICS KOREA INC
ALERE NT-proBNP for Alinity i Controls
AXIS-SHIELD DIAGNOSTICS, LTD.
ALERE NT-proBNP for Alinity i Calibrators
AXIS-SHIELD DIAGNOSTICS, LTD

