ARKRAY PARAHIT Total ver. 1.0 Rapid Test for P.falciparum and Pan Malarial Species – Dipstick (Tropicalised) - Indonesia BPOM Medical Device Registration
ARKRAY PARAHIT Total ver. 1.0 Rapid Test for P.falciparum and Pan Malarial Species – Dipstick (Tropicalised) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303812432. The device is manufactured by ARKRAY HEALTHCARE PVT., LTD. from India, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.
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
ARKRAY HEALTHCARE PVT., LTD.Country of Origin
India
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Jun 09, 2023
Expiry Date
Mar 16, 2028
Product Type
Serological Reagents
Plasmodium species antigen detection assays
Invitro Diagnostics
ARKRAY Spanclone Anti-D (Rho) Monoclonal IgG + IgM
ARKRAY Spanclone Anti - AB Monoclonal
ARKRAY Spanclone Anti - B Monoclonal
ARKRAY Signal MF Flow Through Filarial Antibody Spot/Immunodot Test Kit - Device
ARKRAY ParaHIT Total ver. 1.0 - Rapid Test for P. falciparum and Pan Malarial Species - Device (Tropicalised)
ARKRAY ASO (Anti Streptolysin "O') Latex Test Kit
ARKRAY MBK G-6PD Qualitative Assay
SM MALB Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM Multi Control for Clinical Chemistry Analyzer Level 1
URIT MEDICAL ELECTRONIC CO., LTD
SM TB-DCA Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM DB-DCA Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM – 700 Automatic Chemistry Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
SM FC-73 Flow Cytometer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 3 Diff
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 5 Diff
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 5 Diff (Normal Level)
URIT MEDICAL ELECTRONIC CO., LTD
SM 420 Automatic Chemistry Analyzer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD

