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510(k) Data Aggregation

    K Number
    K142993
    Device Name
    QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
    Manufacturer
    ORION DIAGNOSTICA OY
    Date Cleared
    2016-03-10

    (511 days)

    Product Code
    DCK, JJQ, JJX
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORION DIAGNOSTICA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QuikRead go® CRP: The QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin whole blood, K2-EDTA and lithium heparin plasma and in serum samples. The test is carried out by means of the QuikRead go® instrument. Measurement of C-reactive protein aids in the evaluation of injury to body tissues, and inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point-of-care use. QuikRead go® CRP Control Set: The QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go® CRP assay with the QuikRead go® Instrument. For in vitro diagnostic use. QuikRead go® CRP Verification Set: The QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. This assayed verification material is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. For in vitro diagnostic use. QuikRead go® Instrument: The Orion Diagnostica QuikRead go® is an in vitro diagnostic test system. The QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. Not for point-of-care use.
    Device Description
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    K Number
    K043125
    Device Name
    ORION DIAGNOSTICA UNIQ PINP RIA
    Manufacturer
    ORION DIAGNOSTICA OY
    Date Cleared
    2005-05-04

    (173 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORION DIAGNOSTICA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orion Diagnostica UniQ™ PINP RIA is a quantitative radioimmunoassay designed for the measurement of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum. The test is intended to be used an aid in the management of postmenopausal osteoporosis. For in vitro diagnostic use.
    Device Description
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    K Number
    K042625
    Device Name
    QUIKREAD CRP CALIBRATOR SET
    Manufacturer
    ORION DIAGNOSTICA OY
    Date Cleared
    2004-11-18

    (52 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORION DIAGNOSTICA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation of the QuikRead CRP System. For in vitro diagnostic use.
    Device Description
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    K Number
    K042442
    Device Name
    QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
    Manufacturer
    ORION DIAGNOSTICA OY
    Date Cleared
    2004-09-24

    (15 days)

    Product Code
    DCK, JJX
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORION DIAGNOSTICA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orion Diagnostica QuikRead CRP is a quantitative assay of CRP (C-reactive protein) in whole blood or plasma, using QuikRead® 101 Instrument. Measurement of CRP helps to evaluate the acute inflammatory processes induced by infectious microbial agents or non-infectious inflammatory stimuli. QuikRead CRP Control Set is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument. For in vitro diagnostic use.
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