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DETERMINE™ HIV Controls - Indonesia BPOM Medical Device Registration

DETERMINE™ HIV Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305123262. The device is manufactured by ABBOTT DIAGNOSTICS MEDICAL CO., LTD from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ALERE HEALTH.

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BPOM Registered
Risk Class Kelas Resiko : B
DETERMINE™ HIV Controls
Analysis ID: AKL 20305123262

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Japan

Authorized Representative

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

Feb 10, 2025

Expiry Date

Jan 15, 2029

Product Type

Immunological Test System

Multiple autoantibodies immunological test system.

Invitro Diagnostics

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