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510(k) Data Aggregation

    K Number
    K132090
    Device Name
    BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2013-08-08

    (27 days)

    Product Code
    DLJ, LAS
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Randox Benzodiazepine Calibrator Set: The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only. Randox Benzodiazepine Controls Level 1 & 2: The Randox Benzodiazepine Controls are liquid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
    Device Description
    The Benzodiazepine Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam. The Calibrators are spiked at 4 different levels which assess below, at and above the cutoff of 200 ng/ml. The Benzodiazepine Controls are manufactured at two levels, one below the cutoff and one above the cutoff of 200 ng/ml. The base matrix used for the manufacture of Randox Benzodiazepine Calibrators and Controls is Drug Free Human Urine. The Benzodiazepine Calibrators and Controls contain the specific drug Oxazepam. The Oxazepam is supplied by Cerilliant Corporation the accuracy of which is ensured by purity determinations (GC/FID, HPLC and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights. Randox Benzodiazepine Calibrators and Controls have been designed for in vitro diagnostic use only. They should not be pipetted by mouth and the normal precautions for handling laboratory reagents should be applied. Randox Benzodiazepine Calibrators and Controls contain sodium azide at 0.05%.
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    K Number
    K091617
    Device Name
    QMS LIDOCAINE CALIBRATORS, MODEL 0374678
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2009-07-17

    (44 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QMS Lidocaine Calibrator set is intended for use in calibration of the QMS Lidocaine assay.
    Device Description
    The QMS Lidocaine Calibrator set is a six-level set (0, 0.5, 1.0, 10 µg/mL) of single analyte (lidocaine) calibrators.
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    K Number
    K082030
    Device Name
    DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2008-08-22

    (36 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.
    Device Description
    The Dimension Vista® Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of three vials of Calibrator A (200 ng/mL) and three vials of Calibrator B (2000 ng/mL). The intermediate calibrator levels (400. 800 and 1400 ng/mL) are prepared on-board the Dimension® Vista analyzer.
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    K Number
    K062182
    Device Name
    DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-09-14

    (45 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension Vista™ System.
    Device Description
    EXTC CAL is a liquid, human urine-based product containing weighed-in quantities of methylenedioxymethamphetamine. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B. EXTC CAL is ready for use (no preparation is required). The volume per vial is 2.3 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.
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    K Number
    K062199
    Device Name
    DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-09-06

    (36 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRUG 3 CAL is an in vitro diagnostic product for the calibration of Cyclosporine (CSA) method on the Dimension Vista™ System.
    Device Description
    DRUG 3 CAL is a frozen, liquid, human whole blood hemolysate containing cyclosporine. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are frozen. The volume for Calibrator A is 2.0 mL per vial and for Calibrator B is 1.5 mL per vial. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.
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    K Number
    K061503
    Device Name
    DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-06-22

    (21 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system and the Syva® Emit® 2000 Cyclosporine assay.
    Device Description
    The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of 2 sets of the following: one vial of sample diluent (0.0 ng/ml of cyclosporine ) and one vial of levels 1 through 5. Target concentrations for the five calibrator levels are approximately 200, 400, 800, 1400 and 2000 ng/ml of cyclosporine. Level 0 is included for dilution of over-range samples (>2000 ng/mL) in order to obtain results within the assay range; it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method.
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    K Number
    K060503
    Device Name
    DIMENSION TACR CALIBRATOR, MODEL DC107
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-05-18

    (83 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.
    Device Description
    The Dimension® TACR Calibrator is a stabilized human whole blood hemolysate product containing tacrolimus. The kit consists of two vials of each calibrator level 1-5. The target concentrations are approximately 0, 3, 6, 12, 32.5 ng/mL tacrolimus.
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    K Number
    K053108
    Device Name
    DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-02-16

    (104 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSAE Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® clinical chemistry system Cyclosporine Fr, it® 2000 Cyclosporine Specific Assay.
    Device Description
    The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of one vial of each calibrator level 0-5. The target concentrations of the calibrator levels are approximately 0, 200, 400, 800, 1400 and 2000 ng/mL of cyclosporine. Level 0 is used for dilution of over-range samples (>2000 ng/mL) in order to obtain Lover o lood for analyange; it is not used in calibration. Levels 1 through 5 are used for calibration of the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system or the Syva® Emit® 2000 Cyclosporine Specific Assay.
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    K Number
    K052015
    Device Name
    DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2005-09-12

    (48 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system.
    Device Description
    The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of 2 sets of the following: one vial of sample diluent (0.0 ng/ml of cyclosporine) and one vial of levels 1 through 5. The target concentrations for the five calibrator levels are approximately 200, 400, 800, 1400 and 2000 ng/ml of cyclosporine. Level 0 is included for dilution of over-range samples (>2000 ng/mL) in order to obtain a result; it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method. Refer to the method insert sheet for instructions on calibration and making appropriate manual dilutions.
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    K Number
    K033601
    Device Name
    LABONE MICRO-PLATE COTININE EIA
    Manufacturer
    LABONE, INC.
    Date Cleared
    2004-02-10

    (88 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Product Code :

    DLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only. The LabOne Microplate Cotinine Calibrators are a device intended for medical purposes for use with the LabOne Microplate Cotinine assay to establish points of reference that are used in determination of values in the measurement of cotinine in saliva. The LabOne Microplate Cotinine Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cotinine.
    Device Description
    LabOne Micro-Plate Cotinine EIA is a solid phase competitive enzyme immunoassay for the qualitative and semi-quantitative analysis of cotinine in oral fluid specimens collected with the OraSure® Oral Specimen Collection Device.
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