BEUDAMED
    5 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Terminated × Clear all

    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

    FDA Enforcement
    Class III ·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018

    CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description  Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.

    FDA Enforcement
    Class III ·Terminated·Lab Vision Corporation·February 24, 2016

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490

    FDA Enforcement
    Class III ·Terminated·Datascope Corporation·June 13, 2018

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

    FDA Enforcement
    Class III ·Terminated·Datascope Corporation·June 13, 2018

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

    FDA Enforcement
    Class III ·Terminated·Datascope Corporation·June 13, 2018