BEUDAMED
    1,461 results · 13ms · Sources: EU EUDAMED, US FDA

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    FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.

    FDA Recall
    Terminated ·Qualigen Inc·Product code LTJ·November 8, 2013

    ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code LTJ·March 5, 2018

    Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code LTJ·January 8, 2008

    PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    FDA Recall
    Terminated ·BioCheck Inc·Product code LTJ·December 22, 2010

    Free PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    FDA Recall
    Terminated ·BioCheck Inc·Product code LTJ·December 22, 2010

    ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code LTJ·August 9, 2016

    Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.

    FDA Recall
    Terminated ·Dade Behring Inc Rte 896, Glasgow Business Community·Product code LTJ·April 21, 2003

    Roche Elecsys total PSA, catalog number 11731262322.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LTJ·December 7, 2005

    Roche Elecsys total PSA CalSet, catalog number 11731696322.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LTJ·December 7, 2005

    COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy.

    FDA Recall
    Terminated ·Siemens Medical Solutions Diagnostics·Product code LTJ·May 21, 2008

    FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.

    FDA Recall
    Terminated ·Qualigen Inc·Product code LTJ·September 29, 2008

    CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.

    FDA Enforcement
    Class II ·Terminated·Metrex Research, LLC.·March 15, 2017

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014

    VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014

    VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014