ALINITY i Total PSA Controls - Indonesia BPOM Medical Device Registration
ALINITY i Total PSA Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306811624. The device is manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION from Ireland, 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
ABBOTT IRELAND DIAGNOSTICS DIVISIONCountry of Origin
Ireland
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Mar 24, 2022
Expiry Date
Jan 31, 2027
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
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ARCHITECT Calcium2
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ARCHITECT Total T4 Reagent Kit
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MITRACLIP G4 Steerable Guide Catheter
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CELL-DYN Emerald 22 Diluent
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