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Found 8 results
510(k) Data Aggregation
K Number
K973143Device Name
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
Manufacturer
Date Cleared
1997-09-25
(34 days)
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL REAGENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is intended for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XII. Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
Device Description
Factor deficient plasma to be free of antigen of Factor XII utilized in in vitro diagnostic use. Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
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K Number
K972286Device Name
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
Manufacturer
Date Cleared
1997-07-14
(25 days)
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL REAGENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is intended for use in the quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI.
Device Description
Factor deficient plasma to be free of antigen of Factor XI utilized in in vitro diagnostic use. Factor immunodeficient plasma XI is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
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K Number
K972288Device Name
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
Manufacturer
Date Cleared
1997-07-14
(25 days)
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL REAGENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is intended for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, IX.
Device Description
Factor Deficient Coagulation Plasma Factor - IX (nine) is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
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K Number
K970593Device Name
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
Manufacturer
Date Cleared
1997-04-25
(66 days)
Product Code
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL REAGENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated use - Factor deficient plasma, Factor - VIII is a human plasma immunodepleted of the indication and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
Device Description
Factor deficient plasma to be free of antigen of Factor VIII utilized in in vitro diagnostic use.
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K Number
K970607Device Name
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
Manufacturer
Date Cleared
1997-04-25
(66 days)
Product Code
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL REAGENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated use - Factor deficient plasma, Factor - VII is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
Device Description
Factor deficient coagulation plasma - VII is a human plasma immunodepleted of the specific factor and intended for use in in vitro diagnostic use.
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K Number
K964270Device Name
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
Manufacturer
Date Cleared
1996-12-18
(54 days)
Product Code
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL REAGENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated use - Factor deficient plasma, Factor - V is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
Environment of use: Clinical laboratories
Device Description
Factor deficient plasma to be free of antigen of Factor V utilized in in vitro diagnostic use
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K Number
K964459Device Name
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
Manufacturer
Date Cleared
1996-12-18
(41 days)
Product Code
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL REAGENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated use - Factor deficient plasma, Factor - X is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
Device Description
Factor deficient plasma to be free of antigen of Factor X utilized in in vitro diagnostic use.
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K Number
K961929Device Name
FACTOR DEFICIENT PLASMA
Manufacturer
Date Cleared
1996-10-10
(146 days)
Product Code
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL REAGENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, XI, XII, XII, is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay. Factor VIII is human plasma and bovine material.
Device Description
Factor deficient plasma to be free of antigen of Factor II, V, VII, VIII, IX, X, XI, XII, respectively, utilized in in vitro diagnostic use.
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