ALINITY i Sirolimus Reagent Kit - Indonesia BPOM Medical Device Registration
ALINITY i Sirolimus Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103027499. The device is manufactured by FUJIREBIO DIAGNOSTICS, INC from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ABBOTT PRODUCTS INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
FUJIREBIO DIAGNOSTICS, INCCountry of Origin
United States
Authorized Representative
ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Dec 03, 2020
Expiry Date
Aug 06, 2025
Product Type
Clinical Toxicology Test System
Sirolimus test system (kit & cair)
Invitro Diagnostics
ARCHITECT BNP Calibrators
ALINITY i CA 19-9XR Controls
ALINITY i BNP Calibrators
ARCHITECT CA 125 II Controls
ARCHITECT CA 125 II Reagent Kit
ARCHITECT CA 125 II Calibrators
ALINITY i HE4 Calibrators
ARCHITECT Tacrolimus Calibrators
ARCHITECT Tacrolimus Reagent Kit
ALINITY i BNP Reagent Kit
ARCHITECT Estradiol Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ARMADA 35 PTA Catheter
ABBOTT VASCULAR COSTA RICA
ARCHITECT PIVKA-II Controls
DENKA CO., LTD.
ARCHITECT PIVKA-II Reagent Kit
DENKA CO., LTD.
ALINITY i PIVKA-II Controls
DENKA CO., LTD.
ALINITY i PIVKA-II Calibrators
DENKA CO., LTD.
XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System
ABBOTT VASCULAR
ALINITY c Calcium2
ABBOTT IRELAND DIAGNOSTICS DIVISION
HI-TORQUE Command 18 LT Guide Wire
ABBOTT VASCULAR
ARCHITECT BNP Controls
FUJIREBIO DIAGNOSTICS, INC.