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AFINION ™ ACR Control - Indonesia BPOM Medical Device Registration

AFINION ™ ACR Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101026947. The device is manufactured by ABBOTT DIAGNOSTICS TECHNOLOGIES AS from Norway, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ALERE HEALTH.

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BPOM Registered
Risk Class Kelas Resiko : B
AFINION ™ ACR Control
Analysis ID: AKL 20101026947

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Norway

Authorized Representative

PT. ALERE HEALTH

AR Address

K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan

Registration Date

Dec 23, 2024

Expiry Date

Jan 15, 2029

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

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