ALINITY i TSH Reagent Kit - Indonesia BPOM Medical Device Registration
ALINITY i TSH Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101713435. The device is manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. from Ireland, and is classified as Risk Class Kelas Resiko : B. 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
ABBOTT IRELAND DIAGNOSTICS DIVISION.Country of Origin
Ireland
Authorized Representative
ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Jul 07, 2021
Expiry Date
Mar 22, 2026
Product Type
Clinical Chemistry Test System
Thyroid stimulating hormone test system (kit & cair)
Invitro Diagnostics
ARCHITECT Total T4 Reagent Kit
ARCHITECT Total T4 Controls
ARCHITECT Estradiol Reagent Kit
ABBOTT Amylase2
ALINITY i Rubella IgG Reagent Kit
ARCHITECT Rubella IgG Reagent Kit
ALINITY i Cyclosporine Calibrators
ARCHITECT 25-OH Vitamin D Reagent Kit
ARCHITECT 25-OH Vitamin D Controls
ARCHITECT Free T4 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.

