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QXDx BCR-ABL %IS Kit - Indonesia BPOM Medical Device Registration

QXDx BCR-ABL %IS Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306220119. The device is manufactured by BIO-RAD LABORATORIES, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL 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
QXDx BCR-ABL %IS Kit
Analysis ID: AKL 20306220119

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Oct 29, 2022

Expiry Date

May 04, 2027

Product Type

Tumor Antigen Immunologic Test System

BCR-ABL quantitation test

Invitro Diagnostics

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