Blood Grouping Reagent Anti-K (Anti-K1) Ortho BioVue® System (K Cassette) - Indonesia BPOM Medical Device Registration

Blood Grouping Reagent Anti-K (Anti-K1) Ortho BioVue® System (K Cassette) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209025270. 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 Reagent Anti-K (Anti-K1) Ortho BioVue® System (K Cassette)

Analysis ID: AKL 20209025270

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

May 04, 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

DJ Fang

MedTech Regulatory Expert

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