FOCUS Dengue NS1 Antigen Cassette - Indonesia BPOM Medical Device Registration
FOCUS Dengue NS1 Antigen Cassette is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220410. The device is manufactured by ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD. from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is FOKUS DIAGNOSTIC INDONESIA.
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.
FOKUS Dengue NS1 Antigen Cassette
Risk Classification
Product Class
Kelas : 2
Country of Origin
India
Authorized Representative
FOKUS DIAGNOSTIC INDONESIAAR Address
Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
Registration Date
Jan 24, 2025
Expiry Date
Feb 18, 2027
Product Type
Serological Reagents
Dengue virus serological reagents
Invitro Diagnostics
DxFLEX with Autoloader and Accessories
BECKMAN COULTER BIOTECHNOLOGY (SUZHOU) CO., LTD.
ClearLLab Control Cells Normal
DASH, INC.
ClearLLab Control Cells Abnormal
DASH, INC.
FOKUS Febrile Antigen O-B Paratyphi
PULSE SCIENTIFIC INC.
IOTest 3 Lysing Solution
IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY.
IOTest 3 Fixative Solution
IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY.
CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5
BECKMAN COULTER, INC.
UNITED IMAGING Digital Mammography X-ray Imaging System
SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD
UNITED IMAGING Medical Linear Accelerator System
SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD
XENTA Procalcitonin (PCT) Detection Kit (Fluorescence Immuno chromatography)
XENTA BIOMEDICAL SCIENCE CO., LTD

