ALINITY i Tacrolimus Calibrators - Indonesia BPOM Medical Device Registration
ALINITY i Tacrolimus Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101028077. 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 PT. ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
FUJIREBIO DIAGNOSTICS, INCCountry of Origin
United States
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Dec 21, 2020
Expiry Date
Aug 05, 2025
Product Type
Clinical Chemistry Test System
Calibrator (cair)
Invitro Diagnostics
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