ARIA Leptospira IgG/IgM Combo Rapid Test - Indonesia BPOM Medical Device Registration
ARIA Leptospira IgG/IgM Combo Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303120571. The device is manufactured by BEIJING GENESEE BIOTECH INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is HERMAN MEDTEK DIAGNOSTICS.
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
BEIJING GENESEE BIOTECH INC.Country of Origin
China
Authorized Representative
HERMAN MEDTEK DIAGNOSTICSAR Address
Jl. Lingkar Luar Barat, Puri Kembangan, Komplek Rukan Puri Mansion Blok A No.16 Kel.Kembangan Selatan Kec.Kembangan, Kota Jakarta Barat, DKI Jakarta
Registration Date
Nov 06, 2021
Expiry Date
Jun 04, 2025
Product Type
Serological Reagents
Leptospira spp. serological reagents.
Invitro Diagnostics
ANSWER Dengue Ag Rapid Test
ANSWER HBsAg Rapid Test
ANSWER Malaria Pf/Pan Ag Rapid Test
ANSWER Malaria Pf/Pv Ag Rapid Test
ANSWER HAV IgG/IgM Rapid Test
ANSWER Syphilis Ab Rapid Test
ANSWER Leptospira IgG/IgM Combo Rapid Test Cassette
ANSWER HCV Ab Plus Rapid Test
ARIA Chlamydia Ag Rapid Test
ARIA Syphilis Ab Rapid Test
ARIA hCG Combo Rapid Test
BEIJING GENESEE BIOTECH, INC
ARIA H. Pylori Ag Rapid Test
BEIJING GENESEE BIOTECH, INC.
ARIA H. Pylori Ab Combo Rapid Test
BEIJING GENESEE BIOTECH, INC.
Electroline 100 Li Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
MDX Hemaline 300 Diluent
URIT MEDICAL ELECTRONIC CO., LTD.
MDX Hemaline 500 Analyzer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD.
MDX Hemaline 300 Analyzer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD.
ARIA FOB-Hi Rapid Test
BEIJING GENESEE BIOTECH, INC
ARIA PSA Semi-Quantitative Rapid Test
BEIJING GENESEE BIOTECH, INC
ARIA Duo Dengue Ag-IgG/IgM Rapid Test
BEIJING GENESEE BIOTECH, INC