PATHFAST™ BRAHMS PCT - Indonesia BPOM Medical Device Registration

PATHFAST™ BRAHMS PCT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220252. The device is manufactured by NIPRO CORPORATION ODATE FACTORY. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NUSANTARA BINA DIAGNOSTIKA.

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BPOM Registered

Risk Class Kelas Resiko : B

PATHFAST™ BRAHMS PCT

Analysis ID: AKL 20303220252

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

NIPRO CORPORATION ODATE FACTORY.

Country of Origin

Japan

Authorized Representative

PT. NUSANTARA BINA DIAGNOSTIKA

AR Address

Pertokoan Bali View No. 35 Jl. Rajawali Pisangan Ciputat, Tangerang Selatan

Registration Date

May 28, 2023

Expiry Date

Oct 13, 2025

Product Type

Serological Reagents

Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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