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ELECSYS HBsAg Confirmatory Test - Indonesia BPOM Medical Device Registration

ELECSYS HBsAg Confirmatory Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305420289. The device is manufactured by ROCHE DIAGNOSTICS GMBH from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is ROCHE INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : D
ELECSYS HBsAg Confirmatory Test
Analysis ID: AKL 30305420289

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Germany

Authorized Representative

ROCHE INDONESIA

AR Address

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi

Registration Date

Jul 04, 2024

Expiry Date

Sep 14, 2028

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

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DJ Fang

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