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ANSWER HBsAG Combo Rapid Test - Indonesia BPOM Medical Device Registration

ANSWER HBsAG Combo Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305120048. The device is manufactured by CTK BIOTECH INC. from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. EXXEL MAIN.

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BPOM Registered
Risk Class Kelas Resiko : D
ANSWER HBsAG Combo Rapid Test
Analysis ID: AKL 30305120048

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

CTK BIOTECH INC.

Country of Origin

United States

Authorized Representative

PT. EXXEL MAIN

AR Address

JALAN RAJAWALI SELATAN.RUKO MULTI GUNA KEMAYORAN BLOK.6N.JAKARTA UTARA

Registration Date

Jun 10, 2022

Expiry Date

Jun 09, 2025

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

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