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DIMENSION VISTA / DIMENSION EXL™ SARS-CoV-2 IgG Calibrator - Indonesia BPOM Medical Device Registration

DIMENSION VISTA / DIMENSION EXL™ SARS-CoV-2 IgG Calibrator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303028155. The device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC. 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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BPOM Registered
Risk Class Kelas Resiko : B
DIMENSION VISTA / DIMENSION EXL™ SARS-CoV-2 IgG Calibrator
Analysis ID: AKL 20303028155

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

Nov 22, 2021

Expiry Date

Jan 28, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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