Neutral Ortho BioVue® System (Neutral Cassette) - Indonesia BPOM Medical Device Registration
Neutral Ortho BioVue® System (Neutral Cassette) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209024512. 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 EMERALINDO ASIA PACIFIC.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS.Country of Origin
United Kingdom
Authorized Representative
EMERALINDO ASIA PACIFICAR Address
Rukan Permata Senayan Blok G 15, Jl. Tentara Pelajar Rt/Rw 009/007, Kel. Grogol Utara Kec. Kebayoran Lama, Jakarta Selatan 12210
Registration Date
Jul 22, 2022
Expiry Date
Jun 21, 2024
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
ORTHO Anti-Human Globulin Anti-lgG, -C3d; polyspecific Ortho BioVue System (Poly Cassette)
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