ORTHO Anti-Cellano (Anti-KEL2) - Indonesia BPOM Medical Device Registration
ORTHO Anti-Cellano (Anti-KEL2) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209320540. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS INC from United States, 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 INCCountry of Origin
United States
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 06, 2023
Expiry Date
Feb 24, 2028
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 Chemistry Products Calibrator Kit 4
VITROS Chemistry Products Calibrator Kit 7
VITROS Chemistry Products Fe Slides
VITROS Chemistry Products % A1c Performance Verifier I
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VITROS Chemistry Products C3 Reagent
VITROS Chemistry Products dTIBC Reagent
VITROS Chemistry Products Calibrator Kit 10
VITROS Chemistry Products TIBC Kit
VITROS Chemistry Products wrCRP Reagent
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