DetermineTM TB LAM Ag - Indonesia BPOM Medical Device Registration
DetermineTM TB LAM Ag is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20302125301. The device is manufactured by ABBOTT DIAGNOSTICS SCARBOROUGH, INC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ALERE HEALTH.
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 DIAGNOSTICS SCARBOROUGH, INCCountry of Origin
United States
Authorized Representative
ALERE HEALTHAR Address
K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan
Registration Date
Aug 30, 2021
Expiry Date
Jul 06, 2025
Product Type
Microbiology Equipment
Microorganism differentiation and identification device.
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