ADVIA 560 Lyse - Indonesia BPOM Medical Device Registration
ADVIA 560 Lyse is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208220096. 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 SIEMENS HEALTHINEERS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIATRON MI PLCCountry of Origin
Hungary
Authorized Representative
SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl. Tahi Bonar Simatupang Kav. 88, Kel. Kebagusan, Kec. Pasar Minggu, Jakarta Selatan, DKI Jakarta
Registration Date
May 13, 2022
Expiry Date
Mar 04, 2025
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 Lyse
FORTACEDX H380 Diluent
DIATRON Aquila Hematology Analyzer with Battery
IMMULITE 2000 Substrate Module 2000T
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DIMENSION GGT Flex Reagent Cartridge
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IMMULITE 2000 Systems GRH Growth Hormone
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DIMENSION Clinical Chemistry System Flex Reagent Cartridge PCHE.
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DIMENSION Creatinine Flex reagent cartridge (CRE2)
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Dimension Automated HDL Cholesterol Flex (AHDL)
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Dimension Alkaline Phosphatase Calibrator ( ALPI CAL )
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DIMENSION MBI Flex reagent cartridge
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ADVIA Centaur VB12 Diluent Ready Pack
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Dimension Phosphorus Flex (PHOS) reagent cartridge
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