ARCHITECT Multi-Assay Manual Diluent - Indonesia BPOM Medical Device Registration
ARCHITECT Multi-Assay Manual Diluent is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208220294. 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 DIVISIONCountry of Origin
Ireland
Authorized Representative
ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Oct 13, 2022
Expiry Date
Apr 04, 2027
Product Type
Hematological Reagents
Blood cell diluents
Invitro Diagnostics
ALINITY c Amylase2
ALINITY c Lactate Dehydrogenase2
ARCHITECT Lactate Dehydrogenase2
ARCHITECT Albumin BCG2
ARCHITECT Cyclosporine Calibrators
ALINITY i Cyclosporine Reagent Kit
ARCHITECT Cyclosporine Reagent Kit
ARCHITECT Calcium2
ALINITY c Calcium2
ALINITY Trigger Solution
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.

