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ALINITY i Free PSA Reagent Kit - Indonesia BPOM Medical Device Registration

ALINITY i Free PSA Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306811054. 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.

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.

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BPOM Registered
Risk Class Kelas Resiko : C
ALINITY i Free PSA Reagent Kit
Analysis ID: AKL 20306811054

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Ireland

Authorized Representative

PT. ABBOTT PRODUCTS INDONESIA

AR Address

WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA

Registration Date

Mar 16, 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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