ALINITY i Methotrexate Controls - Indonesia BPOM Medical Device Registration
ALINITY i Methotrexate Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103916327. The device is manufactured by FUJIREBIO DIAGNOSTICS INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
FUJIREBIO DIAGNOSTICS INC.Country of Origin
United States
Authorized Representative
ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Dec 09, 2022
Expiry Date
Aug 08, 2027
Product Type
Clinical Toxicology Test System
Clinical toxicology control material (kit & cair)
Invitro Diagnostics
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