Blood Grouping Reagents Anti-A (Anti-ABO1) Anti-B (Anti-ABO2) Anti-D (Anti-RH1) Ortho BioVue System (ABD Confirmation Cassette) - Indonesia BPOM Medical Device Registration

Blood Grouping Reagents Anti-A (Anti-ABO1) Anti-B (Anti-ABO2) Anti-D (Anti-RH1) Ortho BioVue System (ABD Confirmation Cassette) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209025325. 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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BPOM Registered

Risk Class Kelas Resiko : C

Blood Grouping Reagents Anti-A (Anti-ABO1) Anti-B (Anti-ABO2) Anti-D (Anti-RH1) Ortho BioVue System (ABD Confirmation Cassette)

Analysis ID: AKL 20209025325

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS

Country of Origin

United Kingdom

Authorized Representative

EMERALINDO ASIA PACIFIC

AR 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

Blood group substances of nonhuman origin for in vitro diagnostic use.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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