FOKUS RF Latex - Indonesia BPOM Medical Device Registration
FOKUS RF Latex is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305320782. The device is manufactured by PULSE SCIENTIFIC INC. from Canada, 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
Manufacturer
PULSE SCIENTIFIC INC.Country of Origin
Canada
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
Mar 22, 2023
Expiry Date
Mar 21, 2026
Product Type
Immunological Test System
Rheumatoid factor immunological test system.
Invitro Diagnostics
FOKUS Febrile Antigen H-A Paratyphi
FOKUS Febrile Antigen H-C Paratyphi
FOKUS Febrile Antigen H-B Paratyphi
FOKUS Febrile Antigen O-A Paratyphi
FOKUS Febrile Antigen O-B Paratyphi
FOKUS Febrile Antigen O-C Paratyphi
FOKUS Febrile Antigen H Typhi
FOCUS Antistreptolysin-O (ASO) Latex Test
FOKUS RPR Antigen Test
FOKUS CRP Latex Test
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