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510(k) Data Aggregation

    K Number
    K981173
    Device Name
    CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1999-01-13

    (287 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cryov Check™ Factor XI Deficient Plasma is recommended for use as a substrate in clot-based Factor XI assays using the activated partial thromboplastin time (APTT).
    Device Description
    Cryo Check™ Factor XI Deficient Plasma is frozen human plasma deficient in the Factor XI coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XI by immunoadsorption. Activity levels of Factor XI are assayed at less than 1% normal levels while all other coagulation factors are within normal ranges.
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    K Number
    K981174
    Device Name
    CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1999-01-13

    (287 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.
    Device Description
    Cryo✓Check™ Factor XII Deficient Plasma is frozen human plasma deficient in the Factor XII coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XII by immunoadsorption. Activity levels of Factor XII are assayed at less than 1% normal levels while all other coagulation factors are greater than 50%.
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    K Number
    K982062
    Device Name
    CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1999-01-13

    (212 days)

    Product Code
    GGW
    Regulation Number
    864.7925
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cryo✓Check™ PNP Platelet Lysate is intended for use in the Platelet Neutralization Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA) in human plasma.
    Device Description
    Cryo Check™ PNP Platelet Lysate is prepared from human platelets obtained from normal healthy donors. The platelets are collected, washed, and resuspended in buffer and then frozen and thawed to yield a suspension of ruptured platelet membranes. This suspension is aliquoted into cryovials and stored frozen.
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    K Number
    K971219
    Device Name
    CRYO CHECK INR VALIDATION SET
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-08-29

    (149 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prothrombin Time (PT) was first described by Quick and is a common method of monitoring oral anticoagulant treatment in patients receiving warfarin and related drugs. The safety and efficacy of oral anticoagulant therapy is dependent on regular and appropriate laboratory monitoring of the PT test which measures the depression of clotting factors II, VII and X. In 1983 the World Health Organization (WHO) described a scheme for PT standardization based on the International Normalized Ratio (INR). The INR is defined as the Prothrombin Ratio (PR) of the patient raised to the power of the International Sensitivity Index (ISI) of the thromboplastin reagent in use such that INR=PR'S! With the recent proliferation in both commercial thromboplastins and automated coagulation analyzers, the number of PT system combinations has increased significantly. This, in conjunction with the increasing prevalence of the INR reporting system, has resulted in a heightened awareness of variability in test results between laboratories reporting INR's. CryoCheck INR Validation Set has been designed to enhance the effective monitoring of oral anticoagulant therapy by providing a set of well characterized warfarinized plasmas with system specific INR assigned ranges. CryoCheck INR Validation Set is indicated for use in monitoring the accuracy and control of oral anticoagulant therapy using the International Normalized Ratio (INR) on a variety of prothrombin time systems. CryoCheck INR Validation Set is not intended for use as calibration or reference plasma and should not be used for calibrating the local International Sensitivity Index (ISI) of commercial. thromboplastins.
    Device Description
    Not Found
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    K Number
    K971222
    Device Name
    CRYO CHECK APC RESISTANT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-08-19

    (139 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.
    Device Description
    CryoCheck APC Resistant Plasma
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    K Number
    K971223
    Device Name
    CRYO CHECK FACTOR V DEFICIENT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-07-22

    (111 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CryoCheck Factor V Deficient Plasma is human plasma deficient in the factor V coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor V deficiencies in in vitro clot-based factor V assays using the one stage prothrombin time.
    Device Description
    CryoCheck Factor V Deficient Plasma is human plasma deficient in the factor V coagulation protein while having all other coagulation factors within normal limits.
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    K Number
    K971226
    Device Name
    CRYO CHECK FACTOR IX DEFICIENT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-07-18

    (107 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CryoCheck Factor IX Deficient Plasma is human plasma deficient in the factor IX coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor IX deficiencies in in vitro clot-based factor IX assays using the activated partial thromboplastin time.
    Device Description
    CryoCheck Factor IX Deficient Plasma is human plasma deficient in the factor IX coagulation protein while having all other coagulation factors within normal limits.
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    K Number
    K971227
    Device Name
    CRYO CHECK FACTOR X DEFICIENT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-07-18

    (107 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor X deficiencies in in vitro clot-based factor X assays using the one stage prothrombin time.
    Device Description
    CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits.
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    K Number
    K971224
    Device Name
    CRYO CHECK FACTOR VII DEFICIENT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-07-17

    (106 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VII deficiencies in in vitro clot-based factor VII assays using the one stage prothrombin time.
    Device Description
    CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits.
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    K Number
    K971225
    Device Name
    CRYO CHECK FACTOR VIII DEFICIENT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-07-17

    (106 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOLOGICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VIII deficiencies in in vitro clotbased factor VIII assays using the activated partial thromboplastin time.
    Device Description
    CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits.
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