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STANDARD™ F COVID-19 Ag FIA - Indonesia BPOM Medical Device Registration

STANDARD™ F COVID-19 Ag FIA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303024809. The device is manufactured by SD BIOSENSOR INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. 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™ F COVID-19 Ag FIA
Analysis ID: AKL 20303024809

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SD BIOSENSOR INC.

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

Jun 14, 2021

Expiry Date

Sep 30, 2024

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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