BIOLINE™ Dengue IgG/IgM WB - Indonesia BPOM Medical Device Registration
BIOLINE™ Dengue IgG/IgM WB is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303122584. The device is manufactured by ABBOTT DIAGNOSTICS KOREA INC from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ALERE HEALTH.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ABBOTT DIAGNOSTICS KOREA INCCountry of Origin
Korea
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
Jan 12, 2025
Expiry Date
Jan 15, 2029
Product Type
Serological Reagents
Dengue virus serological reagents
Invitro Diagnostics
Bioline™ HCV
BIOLINE Salmonella Typhi IgG/IgM Fast
BIOLINE™ Dengue NS1 Ag
BIOLINE™ Rotavirus
BIOLINE™ Dengue Duo
BIOLINE™ Dengue IgG/IgM
UroColor Control
UroMeter 720 Urine Chemistry Analyzer
UroColor 11
Positive Controls for PANBIO™ Covid-19/Flu A&B Rapid Panel
DETERMINE HBsAg 2
ABBOTT DIAGNOSTICS MEDICAL CO., LTD.
Bioline™ HCV
ABBOTT DIAGNOSTICS KOREA INC
BIOLINE Salmonella Typhi IgG/IgM Fast
ABBOTT DIAGNOSTICS KOREA INC
AFINION™ Lipid Panel Control
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
DETERMINE™ HIV Early Detect
ABBOTT DIAGNOSTICS MEDICAL CO., LTD
BIOLINE™ Dengue NS1 Ag
ABBOTT DIAGNOSTICS KOREA INC
BIOLINE™ Rotavirus
ABBOTT DIAGNOSTICS KOREA INC
AFINION™ Lipid Panel
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
BIOLINE™ Dengue Duo
ABBOTT DIAGNOSTICS KOREA INC
ALERE NT-proBNP for Alinity i Controls
AXIS-SHIELD DIAGNOSTICS, LTD.

