ARCHITECT Sirolimus Whole Blood Precipitation Reagent - Indonesia BPOM Medical Device Registration
ARCHITECT Sirolimus Whole Blood Precipitation Reagent is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103320565. 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, INC.Country 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
Oct 27, 2023
Expiry Date
Mar 14, 2028
Product Type
Clinical Toxicology Test System
Sirolimus test system (kit & cair)
Invitro Diagnostics
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