IMMUNOCENTRIX Leptospira IgM - Indonesia BPOM Medical Device Registration
IMMUNOCENTRIX Leptospira IgM is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321099. The device is manufactured by IMMUNOCENTRIX from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BESTARI SUKSES MAKMUR.
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
IMMUNOCENTRIXCountry of Origin
United States
Authorized Representative
PT. BESTARI SUKSES MAKMURAR Address
Kokan Permata Kelapa Gading Blok E No. 5 Jl. Boulevard Bukit Gading Raya, Kel. Gading Barat, Kec. Kelapa Gading, Jakarta Utara
Registration Date
Apr 20, 2023
Expiry Date
Dec 31, 2025
Product Type
Serological Reagents
Leptospira spp. serological reagents.
Invitro Diagnostics
InBios DENVโข Detect IgM Capture ELISA
INBIOS INTERNATIONAL, INC
HYBRIBIO DNA Prep Kit
CHAOZHOU HYBRIBIO BIOCHEMISTRY LTD
HYBRIBIO 14 High-risk HPV with 16/18 Genotyping Real-time PCR Kit
CHAOZHOU HYBRIBIO BIOCHEMISTRY LTD
EZITELL Malaria P.f./Pan Rapid Test Cassette (Whole Blood)
HANGZHOU ALLTEST BIOTECH CO., LTD.
BIOPANDA Typhoid IgG/IgM Rapid Test
BIOPANDA REAGENTS LTD
HYBRIBIO Beta Thalassemia GenoArray Diagnostic Kit
GUANGZHOU HYBRIBIO MEDICINE TECHNOLOGY LTD
HYBRIBIO Alpha Thalassemia Genoarray Diagnostic Kit
GUANGZHOU HYBRIBIO MEDICINE TECHNOLOGY LTD MELALUI HYBRIBIO LIMITED
HYBRIBIO DNA Hybrimax
GUANGZHOU HYBRIBIO MEDICINE TECHNOLOGY LTD
INBIOS JE Detectโข IgM Antibody CAPTURE ELISA (MAC-ELISA)
INBIOS INTERNATIONAL, INC.
BIOPANDA Dengue Combo Rapid Test Cassette
BIOPANDA DIAGNOSTICS

