FOKUS Urine Sediment Negative Control - Indonesia BPOM Medical Device Registration
FOKUS Urine Sediment Negative Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101422248. The device is manufactured by BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.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
Nov 01, 2024
Expiry Date
Oct 31, 2027
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
FOKUS Urine Sediment Positive Control
FOKUS DIAGNOSTIC Urine Sediment Analyzer
FOKUS Urine Test Strip
BIOWAY URS-3 Reagent Strips for Urinalysis (Glucose, Protein, pH)
FOCUS Urine Test Strip URS-3
FOCUS Urine Test Strip URS-1
FOKUS Urine Test Strip
FOKUS Urine Test Strip
FOKUS Urine QC Positive Control Set
FOKUS Urine QC Negative Control Set
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