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ALINITY i SCC Controls - Indonesia BPOM Medical Device Registration

ALINITY i SCC Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306915822. The device is manufactured by DENKA SEIKEN CO.,LTD from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ABBOTT PRODUCTS INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
ALINITY i SCC Controls
Analysis ID: AKL 20306915822

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Japan

Authorized Representative

ABBOTT PRODUCTS INDONESIA

AR Address

Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA

Registration Date

Jun 04, 2024

Expiry Date

Oct 17, 2028

Product Type

Tumor Antigen Immunologic Test System

Immunomagnetic circulating cancer cell selection and enumeration system.

Invitro Diagnostics

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