ALINITY i Cortisol Calibrators - Indonesia BPOM Medical Device Registration
ALINITY i Cortisol Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101811423. The device is manufactured by FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, 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
Country 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
Apr 04, 2022
Expiry Date
Jan 31, 2027
Product Type
Clinical Chemistry Test System
Calibrator (cair)
Invitro Diagnostics
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