ALINITY i Insulin Calibrators - Indonesia BPOM Medical Device Registration
ALINITY i Insulin Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323042. The device is manufactured by DENKA, CO. LTD from Japan, 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
DENKA, CO. LTDCountry of Origin
Japan
Authorized Representative
ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
May 10, 2023
Expiry Date
Mar 21, 2027
Product Type
Clinical Chemistry Test System
Immunoreactive insulin test system (kit & cair)
Invitro Diagnostics
ALINITY i Insulin Controls
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ALINITY i TRAb Controls
ALINITY i TRAb Calibrators
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ARCHITECT PIVKA-II Reagent Kit
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ALINITY i PIVKA-II Controls
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ALINITY i PIVKA-II Calibrators
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FUJIREBIO DIAGNOSTICS, INC.

