ALINITY c-series ICT Reference Solution - Indonesia BPOM Medical Device Registration
ALINITY c-series ICT Reference Solution is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101713727. The device is manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.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
Aug 21, 2024
Expiry Date
Jan 10, 2029
Product Type
Clinical Chemistry Test System
Multi parameter clinical chemistry test system
Invitro Diagnostics
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