AIKANG Free Prostate Specific Antigen In Vitro Diagnostic Kit (Chemiluminescent Immunoassay) - Indonesia BPOM Medical Device Registration

AIKANG Free Prostate Specific Antigen In Vitro Diagnostic Kit (Chemiluminescent Immunoassay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306520017. The device is manufactured by AIKANG DIAGNOSTICS CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BIOGEN SCIENTIFIC.

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BPOM Registered

Risk Class Kelas Resiko : C

AIKANG Free Prostate Specific Antigen In Vitro Diagnostic Kit (Chemiluminescent Immunoassay)

Analysis ID: AKL 20306520017

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

AIKANG DIAGNOSTICS CO., LTD.

Country of Origin

China

Authorized Representative

PT. BIOGEN SCIENTIFIC

AR Address

Rukan Tanjung Mas Raya Jl.Raya Lenteng Agung Blok B1 No.21 RT.002/RW.001 Tanjung Barat, Jagakarsa, Jakarta Selatan, DKI Jakarta

Registration Date

Feb 01, 2025

Expiry Date

Dec 30, 2025

Product Type

Tumor Antigen Immunologic Test System

Complexed Prostate Specific Antigen (CPSA) Immunological Test System

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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