PLATINUM Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) - Indonesia BPOM Medical Device Registration

PLATINUM Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420164. The device is manufactured by CITEST DIAGNOSTICS INC from Canada, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PLATINUM MEDLAB INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : C

PLATINUM Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)

Analysis ID: AKL 20303420164

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

CITEST DIAGNOSTICS INC

Country of Origin

Canada

Authorized Representative

PT. PLATINUM MEDLAB INDONESIA

AR Address

Jl Raya Caman No.54 Jatibening Bekasi

Registration Date

Apr 30, 2024

Expiry Date

Dec 05, 2026

Product Type

Serological Reagents

Dengue virus serological reagents

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Kelas Resiko : B

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