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OnSite Duo Dengue Ag-IgG/IgM Rapid Test - Indonesia BPOM Medical Device Registration

OnSite Duo Dengue Ag-IgG/IgM Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303127121. The device is manufactured by CTK BIOTECH, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. RAJAERBA INDOCHEM.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : C
OnSite Duo Dengue Ag-IgG/IgM Rapid Test
Analysis ID: AKL 20303127121

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

CTK BIOTECH, INC.

Country of Origin

United States

Authorized Representative

PT. RAJAERBA INDOCHEM

AR Address

Jl. Hj. Tutty Alawiyah No. 8, Desa/Kelurahan Duren Tiga, Kec. Pancoran, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12760

Registration Date

Nov 21, 2024

Expiry Date

Sep 09, 2027

Product Type

Serological Reagents

Dengue virus serological reagents

Invitro Diagnostics

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