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PANBIO™ COVID-19 Ag Rapid Test Device - Indonesia BPOM Medical Device Registration

PANBIO™ COVID-19 Ag Rapid Test Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303025616. The device is manufactured by ABBOTT DIAGNOSTICS KOREA INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ALERE HEALTH.

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
PANBIO™ COVID-19 Ag Rapid Test Device
Analysis ID: AKL 20303025616

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

PT. ALERE HEALTH

AR Address

K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan

Registration Date

Feb 22, 2022

Expiry Date

Jul 06, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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