ALINITY c Iron Calibrator Kit - Indonesia BPOM Medical Device Registration
ALINITY c Iron Calibrator Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101917533. The device is manufactured by MICROGENICS CORPORATION 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
MICROGENICS CORPORATIONCountry 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 10, 2023
Expiry Date
Jan 11, 2028
Product Type
Clinical Chemistry Test System
Calibrator (cair)
Invitro Diagnostics
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