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P4DETECT COVID-19 IgM/IgG - Indonesia BPOM Medical Device Registration

P4DETECT COVID-19 IgM/IgG is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303026018. The device is manufactured by PRIME4DIA CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is INDOCORE PERKASA.

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 : B
P4DETECT COVID-19 IgM/IgG
Analysis ID: AKL 20303026018

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

INDOCORE PERKASA

AR Address

Komplek Graha Mas Pemuda Blok AB No. 19, Jl. Pemuda RT 020 / RW 006 Kel. Jati, Kec. Pulo Gadung, Jakarta Timur, DKI Jakarta

Registration Date

Jun 10, 2021

Expiry Date

Aug 04, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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