BEUDAMED
    21 results · 60ms · Sources: EU EUDAMED, US FDA

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    A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·January 29, 2020

    PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·July 4, 2012

    PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·January 1, 2020

    Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·January 29, 2020

    Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·January 29, 2020

    PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·January 29, 2020

    PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·June 5, 2013

    PTS Panels¿ CHOL+GLU Test Strips (REF 1765)

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·May 9, 2018

    Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·May 29, 2019

    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·May 29, 2019

    CHOL+HDL+GLU test strips, REF 2412

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·May 29, 2019

    PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

    FDA Enforcement
    Class III ·Terminated·Polymer Technology Systems, Inc.·August 14, 2019

    Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

    FDA Enforcement
    Class III ·Terminated·Polymer Technology Systems, Inc.·August 14, 2019

    PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·March 11, 2020

    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Enforcement
    Class II ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·October 30, 2024