ADVIA Chemistry Direct Bilirubin_2 (DBIL_2) Reagents - Indonesia BPOM Medical Device Registration

ADVIA Chemistry Direct Bilirubin_2 (DBIL_2) Reagents is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101220471. The device is manufactured by FUJIFILM WAKO PURE CHEMICAL CORPORATION from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is SIEMENS HEALTHINEERS INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

ADVIA Chemistry Direct Bilirubin_2 (DBIL_2) Reagents

Analysis ID: AKL 20101220471

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Country of Origin

Japan

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

Apr 08, 2022

Expiry Date

Mar 04, 2025

Product Type

Clinical Chemistry Test System

Bilirubin (total and unbound) in the neonate test system (kit & cair)

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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