ORTHO Anti-Human Globulin Anti-lgG (Rabbit) (Green) Ortho BioVue System (IgG Cassette) - Indonesia BPOM Medical Device Registration
ORTHO Anti-Human Globulin Anti-lgG (Rabbit) (Green) Ortho BioVue System (IgG Cassette) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420380. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS from United Kingdom, and is classified as Risk Class Kelas Resiko : B. 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 DIAGNOSTICSCountry 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
Aug 26, 2024
Expiry Date
Feb 15, 2027
Product Type
Immunological Test System
Immunoglobulins A, G, M, D, and E immunological test system.
Invitro Diagnostics
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ORTHO Anti-IgG/Anti-C3b, -C3d/Control Ortho BioVue System (DAT/IDAT Cassette)
ORTHO Reverse Diluent Ortho BioVue ยฎ System (Reverse Diluent Cassette)
VITROS Immunodiagnostic Products Free PSA Calibrators
ORTHO Blood Grouping Reagents Anti-A/Anti-B/Anti-D Control /Reverse Diluent Ortho BioVue System (ABO-Rh/Reverse Grouping Cassette)
VITROS Immunodiagnostic Products System Cleaning Solution
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VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
VITROS Immunodiagnostic Products Rubella IgM Calibrator
VITROS Immunodiagnostic Products LH Calibrators
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MGI Genetic Sequencer
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MGI Genetic Sequencer
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ORTHO Pooled Screening Cells
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