IMMUNODIAGNOSTIK Histamine ELISA - Indonesia BPOM Medical Device Registration

IMMUNODIAGNOSTIK Histamine ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305912222. The device is manufactured by IMMUNODIAGNOSTIK AG. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is INTI MAKMUR MEDITAMA.

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BPOM Registered

Risk Class Kelas Resiko : B

IMMUNODIAGNOSTIK Histamine ELISA

Analysis ID: AKL 20305912222

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

IMMUNODIAGNOSTIK AG.

Country of Origin

Germany

Authorized Representative

INTI MAKMUR MEDITAMA

AR Address

JL. SULTAN ISKANDAR MUDA, GANDARIA 8 OFFICE TOWER LANTAI 16 UNIT F, KEBAYORAN LAMA JAKARTA SELATAN

Registration Date

Nov 22, 2023

Expiry Date

Sep 01, 2028

Product Type

Immunological Test System

Radioallergosorbent (RAST) immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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