ARCHITECT HAVAb-IgM Reagent Kit - Indonesia BPOM Medical Device Registration
ARCHITECT HAVAb-IgM Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303714103. The device is manufactured by ABBOTT GmbH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ABBOTT GmbHCountry of Origin
Germany
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
Registration Date
Oct 11, 2024
Expiry Date
Jan 09, 2029
Product Type
Serological Reagents
Hepatitis A virus (HAV) serological assays.
Invitro Diagnostics
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