ORTHO Anti-Human Globulin Anti-lgG, -C3d; polyspecific Ortho BioVue System (Poly Cassette) - Indonesia BPOM Medical Device Registration
ORTHO Anti-Human Globulin Anti-lgG, -C3d; polyspecific Ortho BioVue System (Poly Cassette) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209420296. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS. from United Kingdom, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is DIASTIKA BIOTEKINDO.
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
ORTHO-CLINICAL DIAGNOSTICS.Country of Origin
United Kingdom
Authorized Representative
DIASTIKA BIOTEKINDOAR Address
Rukan Sentra Pemuda Kav.30 - 31 Jalan Pemuda No.61 RT.009 RW.003 Kel. Rawamangun Kec.Pulogadung
Registration Date
Jul 31, 2024
Expiry Date
Feb 15, 2027
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Automated blood grouping and antibody test system.
Invitro Diagnostics
VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator
VITROS Immunodiagnostic Products TSH3 Reagent Pack
VITROS Immunodiagnostic Products C-peptide Reagent Pack
VITROS Immunodiagnostic Products BRAHMS PCT Calibrators
Neutral Ortho BioVueยฎ System (Neutral Cassette)
MGI Universal Sequencing Reaction Kit
WUHAN MGI TECH CO.,LTD
MGI Universal Sequencing Reaction Kit
WUHAN MGI TECH CO.,LTD
MGI DNA Sequencing Library Preparation System
WUHAN MGI TECH CO.,LTD
MGI Genetic Sequencer
WUHAN MGI TECH CO.,LTD
MGI Genetic Sequencer
WUHAN MGI TECH CO.,LTD
ORTHO Pooled Screening Cells
ORTHO-CLINICAL DIAGNOSTICS INC.,
MGI Genetic Sequencer
WUHAN MGI TECH CO.,LTD
ORTHO Vision Analyzer
TECAN SCHWEIZ AG
ORTHO Anti-Human Globulin Anti-lgG (Rabbit) (Green) Ortho BioVue System (IgG Cassette)
ORTHO-CLINICAL DIAGNOSTICS
ORTHO Affirmagen
ORTHO-CLINICAL DIAGNOSTICS INC.,

