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

STANDARD™ Q COVID-19 IgM/IgG Combo Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303024236. The device is manufactured by SD BIOSENSOR. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. STANDARD BIOSENSOR INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
STANDARD™ Q COVID-19 IgM/IgG Combo Test
Analysis ID: AKL 20303024236

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SD BIOSENSOR.

Country of Origin

Korea

Authorized Representative

PT. 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 28, 2021

Expiry Date

Sep 30, 2024

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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