QUIKLYTE Integrated Multisensor Standard A - Indonesia BPOM Medical Device Registration
QUIKLYTE Integrated Multisensor Standard A is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101121978. The device is manufactured by NOVA BIOMEDICAL CORPORATION. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
NOVA BIOMEDICAL CORPORATION.Country of Origin
United States
Authorized Representative
PT. SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
Registration Date
Jan 04, 2025
Expiry Date
Aug 01, 2029
Product Type
Clinical Chemistry Test System
Calibrator (cair)
Invitro Diagnostics
QUIKLYTE Integrated Multisensor Sample Diluent.
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Stat Profile pHOx Ultra™ / CCX™ Mg++ Sensor Blank
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Stat Profile pHOx Ultra™ / CCX™ Creatinine Membrane Kit
STAT PROFILE pHOx Plus/C Controls Auto Cartridge, 330
Stat Profile pHOx Ultra™ / CCX™ Na/pH Sensor Blank
STAT PROFILE Prime + Blood Gas, CO-OX Ampuled Control Level 1,2,3
NOVA 1/4/5/8/10/11/12/13/14 Potassium Sensor
NOVA 8™ pH Sensor
ADVIA Centaur Calibrator D
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DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)
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IMMULITE 2000 Systems Allergen Specific IgE Universal Kit
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IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2
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ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)
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DIMENSION Bilirubin Calibrator (TBI/DBI CAL)
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ADVIA Centaur CA 15-3
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ADVIA Centaur Insulin (IRI)
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CLINITEK Status+ Analyzer and Accessories
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DIMENSION Tacrolimus Calibrator
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