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510(k) Data Aggregation

    K Number
    K201570
    Device Name
    PF4 Enhanced assay
    Manufacturer
    Immucor GTI Diagnostics, Inc.
    Date Cleared
    2020-09-11

    (92 days)

    Product Code
    LCO
    Regulation Number
    864.7695
    Why did this record match?
    Applicant Name (Manufacturer) :

    Immucor GTI Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PF4 Enhanced assay is designed as a solid phase enzyme linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hematology, coagulation, or other pathology laboratories to assist in screening patient samples, 3.2% sodium citrate (plasma) or without anticoagulant (serum), for the presence of heparin associated commonly found in patients with heparin induced thrombocytopenia (HIT) or thrombosis.
    Device Description
    PF4 Enhanced Assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 Enhanced ELISA is intended to detect antibodies in human serum or plasma that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 Enhanced kit contains all of the reagents necessary to perform the assay.
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    K Number
    K201311
    Device Name
    PF4 IgG assay
    Manufacturer
    Immucor GTI Diagnostics, Inc.
    Date Cleared
    2020-06-18

    (31 days)

    Product Code
    LCO
    Regulation Number
    864.7695
    Why did this record match?
    Applicant Name (Manufacturer) :

    Immucor GTI Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PF4 IgG assay is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum or plasma. The presence of heparin-associated antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).
    Device Description
    PF4 IgG assay is an enzyme linked immunosorbent assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum or plasma that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay.
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