FORTACEDX H380 Lyse - Indonesia BPOM Medical Device Registration
FORTACEDX H380 Lyse is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320823. The device is manufactured by DIATRON MI PLC from Hungary, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FORTACE DIAGNOSTICS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIATRON MI PLCCountry of Origin
Hungary
Authorized Representative
PT. FORTACE DIAGNOSTICS INDONESIAAR Address
Jl. Meruya Utara Raya Blok 3 No.1-2
Registration Date
Nov 17, 2023
Expiry Date
Nov 13, 2026
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
FORTACEDX H380 Hematology Control (High Level)
FORTACEDX H380 Hematology Control Set (L-N-H)
FORTACEDX H380 Hematology Control (Normal Level)
FORTACEDX H380 Hematology Control (Low Level)
FORTACEDX H380 Hematology Calibrator
FORTACEDX H380 Cleaner
FORTACEDX H380 Hypoclean CC
FORTACEDX H380 Diluent
DIATRON Aquila Hematology Analyzer with Battery
ADVIA 360 Lyse 3P Diff
FORTACEDX Cholesterol Standard
LINEAR CHEMICALS, S.L.U
FORTACEDX H380 Hematology Control (High Level)
DIATRON MI PLC
FORTACEDX H380 Hematology Control Set (L-N-H)
DIATRON MI PLC
FORTACEDX H380 Hematology Control (Normal Level)
DIATRON MI PLC
FORTACEDX H380 Hematology Calibrator
DIATRON MI PLC
FORTACEDX H380 Hematology Control (Low Level)
DIATRON MI PLC
FORTACEDX H380 Cleaner
DIATRON MI PLC
FORTACEDX H380 Hypoclean CC
DIATRON MI PLC
FORTACEDX H380 Diluent
DIATRON MI PLC
FORTACEDX Cholesterol MR
LINEAR CHEMICALS, S.L.U