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Atellica IM Alpha Fetoprotein (AFP). - Indonesia BPOM Medical Device Registration

Atellica IM Alpha Fetoprotein (AFP). is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306126158. The device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE) from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is SIEMENS HEALTHINEERS INDONESIA.

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Risk Class Kelas Resiko : B
Atellica IM Alpha Fetoprotein (AFP).
Analysis ID: AKL 20306126158

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

SIEMENS HEALTHINEERS INDONESIA

AR Address

Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl. Tahi Bonar Simatupang Kav. 88, Kel. Kebagusan, Kec. Pasar Minggu, Jakarta Selatan, DKI Jakarta

Registration Date

Oct 18, 2021

Expiry Date

Mar 04, 2025

Product Type

Tumor Antigen Immunologic Test System

AFP-L3% immunological test system.

Invitro Diagnostics

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