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STANDARD™ Q COVID-19 IgM/IgG Duo Test - Indonesia BPOM Medical Device Registration

STANDARD™ Q COVID-19 IgM/IgG Duo Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303024208. The device is manufactured by SD BIOSENSOR from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is STANDARD BIOSENSOR INDONESIA.

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
STANDARD™ Q COVID-19 IgM/IgG Duo Test
Analysis ID: AKL 20303024208

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SD BIOSENSOR

Country of Origin

Korea

Authorized Representative

STANDARD BIOSENSOR INDONESIA

AR Address

L'Avenue Office Tower Lt.21 Unit C, Jl. Raya Pasar Minggu Kav.16 Kel. Pancoran Kec. Pancoran , Jakarta Selatan

Registration Date

May 20, 2021

Expiry Date

Sep 30, 2024

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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