SD BIOLINE Malaria Ag P.f/Pan - Indonesia BPOM Medical Device Registration
SD BIOLINE Malaria Ag P.f/Pan is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303310010. The device is manufactured by STANDARD DIAGNOSTICS, INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ALERE HEALTH.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
STANDARD DIAGNOSTICS, INC.Country 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
Nov 16, 2022
Expiry Date
Jun 04, 2027
Product Type
Serological Reagents
Plasmodium species antigen detection assays
Invitro Diagnostics
SD BIOLINE HCV
SD BIOLINE H. Pylori Ag
SD BIOLINE H. Pylori
SD BIOLINE Malaria Ag P.f/P.v
SD BIOLINE HIV/Syphilis Duo
SD BIOLINE HAV IgG/IgM
SD BIOLINE HBsAg
SD Bioline Dengue NS1 Ag
SD UROCOLOR 10 Test Strips for Urinalysis (Blood/ Bilirubin/Urobilinogen/Ketone/Protein/Nitrite/Glucose/pH/Specific Gravity/Leukocytes)
SD BIOLINE Dengue IgG/IgM WB
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.