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Found 11 results
510(k) Data Aggregation
K Number
K981173Device 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
864.7290Why 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
K981174Device 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
864.7290Why 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
K982062Device 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
864.7925Why 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
K971219Device Name
CRYO CHECK INR VALIDATION SET
Manufacturer
PRECISION BIOLOGICALS, INC.
Date Cleared
1997-08-29
(149 days)
Product Code
GGN
Regulation Number
864.5425Why 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
K971222Device Name
CRYO CHECK APC RESISTANT PLASMA
Manufacturer
PRECISION BIOLOGICALS, INC.
Date Cleared
1997-08-19
(139 days)
Product Code
GGN
Regulation Number
864.5425Why 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
K971223Device Name
CRYO CHECK FACTOR V DEFICIENT PLASMA
Manufacturer
PRECISION BIOLOGICALS, INC.
Date Cleared
1997-07-22
(111 days)
Product Code
GJT
Regulation Number
864.7290Why 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
K971226Device Name
CRYO CHECK FACTOR IX DEFICIENT PLASMA
Manufacturer
PRECISION BIOLOGICALS, INC.
Date Cleared
1997-07-18
(107 days)
Product Code
GJT
Regulation Number
864.7290Why 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
K971227Device Name
CRYO CHECK FACTOR X DEFICIENT PLASMA
Manufacturer
PRECISION BIOLOGICALS, INC.
Date Cleared
1997-07-18
(107 days)
Product Code
GJT
Regulation Number
864.7290Why 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
K971224Device Name
CRYO CHECK FACTOR VII DEFICIENT PLASMA
Manufacturer
PRECISION BIOLOGICALS, INC.
Date Cleared
1997-07-17
(106 days)
Product Code
GJT
Regulation Number
864.7290Why 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
K971225Device Name
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
Manufacturer
PRECISION BIOLOGICALS, INC.
Date Cleared
1997-07-17
(106 days)
Product Code
GJT
Regulation Number
864.7290Why 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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