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    Combined KIT

    FDA UDI
    DENTIS CO. ,LTD·08806169135407·Dental Implant Instrument KIT / Combined KIT

    Sterling Medical Products

    FDA UDI
    APOLLO MEDICAL PRODUCTS CORP.·00685404002272·Dialysis Catheter Kit

    Braincare

    FDA UDI
    BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA·07908398200084·External Baterry Charger of Braincare Wirelss N...

    Braincare

    FDA UDI
    BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA·07908398200282·Sensor Charger of Braincare Wireless Non-Invasi...

    VITROS CHEMISTRY PRODUCTS CRP SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DCK·October 27, 2021

    SYNCHRON® SYSTEMS C-REACTVE PROTEIN (C-RP) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DCK·April 5, 2012

    SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DCK·July 7, 2011

    AU5400 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code DCK·November 11, 2014

    VITROS CHEMISTRY PRODUCTS CRP SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DCK·March 3, 2026

    IMMAGE C-REACTIVE PROTEIN REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DCK·January 7, 2008

    C-REACTIVE PROTEIN (LATEX)

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DCK·August 2, 2001

    C-Reactive Protein, Antigen, Antiserum, And Control

    FDA classification
    FDA Class 2 ·C-Reactive Protein, Antigen, Antiserum, And Control

    Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.

    FDA Recall
    Terminated ·Cholestech Corp·Product code DCK·August 9, 2006

    The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DCK·March 6, 2013

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DCK·October 11, 2024

    VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DCK·April 14, 2025

    TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DCK·December 5, 2003

    "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.

    FDA Recall
    Terminated ·Kamiya Biomedical Company, LLC·Product code DCK·May 1, 2009

    VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DCK·October 26, 2016

    VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DCK·June 12, 2013