IDKmonitor Infliximab drug level ELISA - Indonesia BPOM Medical Device Registration

IDKmonitor Infliximab drug level ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305916808. The device is manufactured by IMMUNDIAGNOSTIK AG from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. INTI MAKMUR MEDITAMA.

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BPOM Registered

Risk Class Kelas Resiko : C

IDKmonitor Infliximab drug level ELISA

Analysis ID: AKL 20305916808

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

IMMUNDIAGNOSTIK AG

Country of Origin

Germany

Authorized Representative

PT. INTI MAKMUR MEDITAMA

AR Address

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

Registration Date

Oct 17, 2019

Expiry Date

Feb 18, 2024

Product Type

Immunological Test System

Rheumatoid factor immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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