I-SPOT.TB - Indonesia BPOM Medical Device Registration
I-SPOT.TB is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303121452. The device is manufactured by SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO., LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Country of Origin
China
Authorized Representative
PT. FOCUS DIAGNOSTIC INDONESIAAR Address
Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
Registration Date
Oct 18, 2023
Expiry Date
Aug 14, 2026
Product Type
Serological Reagents
Mycobacterium tuberculosis immunofluorescent reagents.
Invitro Diagnostics
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