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ALINITY i SARS-CoV-2 IgM Control Kit - Indonesia BPOM Medical Device Registration

ALINITY i SARS-CoV-2 IgM Control Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303025731. 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 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 : B
ALINITY i SARS-CoV-2 IgM Control Kit
Analysis ID: AKL 20303025731

Risk Classification

Kelas Resiko : B

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

May 03, 2021

Expiry Date

Apr 27, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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