AIKANG Myoglobin in vitro diagnostic kit (Chemiluminescent Immunoassay) - Indonesia BPOM Medical Device Registration

AIKANG Myoglobin in vitro diagnostic kit (Chemiluminescent Immunoassay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420564. The device is manufactured by AIKANG DIAGNOSTICS CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is BIOGEN SCIENTIFIC.

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.

Free Database

Powered by Pure Global AI

BPOM Registered

Risk Class Kelas Resiko : B

AIKANG Myoglobin in vitro diagnostic kit (Chemiluminescent Immunoassay)

Analysis ID: AKL 20305420564

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

AIKANG DIAGNOSTICS CO., LTD.

Country of Origin

China

Authorized Representative

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

Nov 13, 2024

Expiry Date

Dec 30, 2025

Product Type

Immunological Test System

Myoglobin immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from AIKANG DIAGNOSTICS CO., LTD.

Products from the same manufacturer (10 products)

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

Kelas Resiko : C

AIKANG AMH in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : B

AIKANG Estradiol in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : B

AIKANG Alpha-fetoprotein in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : B

AIKANG Testosterone in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : B

AIKANG Carbohydrate Antigen 125 in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : C

AIKANG Progesterone in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : B

AIKANG Total Thyroxine in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : B

AIKANG Ferritin in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : B

AIKANG Free Thyroxine in vitro diagnostic kit (Chemiluminescent Immunoassay)

Kelas Resiko : B

Other Products from BIOGEN SCIENTIFIC

Products with the same authorized representative (10 products)

LEICA BOND Primary Antibody Diluent

LEICA BIOSYSTEMS NEWCASTLE LTD.

Kelas Resiko : A

LEICA BOND™ bcl-6 (LN22)

LEICA BIOSYSTEMS NEWCASTLE LTD.

Kelas Resiko : A

LEICA BOND™ CD34 (QBEnd/10)

LEICA BIOSYSTEMS NEWCASTLE LTD.

Kelas Resiko : A

LEICA Novocastra ™ Liquid Mouse Monoclonal Antibody Inhibin Alpha

LEICA BIOSYSTEMS NEWCASTLE LTD

Kelas Resiko : A

LEICA NOVOCASTRA™ Novolink™ Polymer Detection System

LEICA BIOSYSTEMS NEWCASTLE LTD.

Kelas Resiko : A

LEICA NOVOCASTRA IHC Diluent

LEICA BIOSYSTEMS NEWCASTLE LTD.

Kelas Resiko : A

LEICA NOVOCASTRA Epitope Retrieval Solution

LEICA BIOSYSTEMS NEWCASTLE LTD.

Kelas Resiko : A

LEICA NOVOCASTRA Epitope Retrieval Solution pH 9 (x10 Concentrate)

LEICA BIOSYSTEMS NEWCASTLE LTD.

Kelas Resiko : A

LEICA HistoCore BIOCUT and Accessories

LEICA MICROSYSTEMS LTD. SHANGHAI

Kelas Resiko : A

LEICA HistoCore AUTOCUT and Accessories

LEICA MICROSYSTEMS LTD. SHANGHAI

Kelas Resiko : A