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510(k) Data Aggregation
K Number
K150144Device Name
VisuCon-F Low Fibrinogen Control Plasma
Manufacturer
AFFINITY BIOLOGICALS INC.
Date Cleared
2016-03-06
(409 days)
Product Code
GGN
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
AFFINITY BIOLOGICALS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".
Device Description
The VisuCon-F Low Fibrinogen Control plasma is a pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
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K Number
K110432Device Name
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
Manufacturer
AFFINITY BIOLOGICALS INC.
Date Cleared
2011-10-20
(247 days)
Product Code
GGN
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
AFFINITY BIOLOGICALS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VisuCon-F Frozen Coag Screen N plasma is an assayed normal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTT) and fibrinogen, in the normal range. The VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
The VisuCon-F Frozen Coag Screen ABN plasma is an assayed abnormal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated partial thromboplastin time (APTT), in the mid-level abnormal range. The VisuCon-F Frozen Coag Screen ABN plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
Device Description
The VisuCon-F Frozen Coag Screen N is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
The VisuCon-F Frozen Coag Screen ABN is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
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K Number
K091284Device Name
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
Manufacturer
AFFINITY BIOLOGICALS INC.
Date Cleared
2009-10-28
(180 days)
Product Code
GGN, JIX
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
AFFINITY BIOLOGICALS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coaqulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coaqulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor.
The VisuCon-F Frozen Abnormal Control plasma is intended for use in the quality control of coagulation assays in the borderline pathological range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.
The VisuCon-F Frozen Normal Control plasma is intended for use in the quality control of coagulation assays in the normal range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.
Device Description
The VisuCal-F Frozen Calibrator Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
The VisuCon-F Frozen Normal Control Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
The VisuCon-F Frozen Abnormal Control Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
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K Number
K052825Device Name
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
Manufacturer
AFFINITY BIOLOGICALS INC.
Date Cleared
2006-01-20
(107 days)
Product Code
GGP
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
AFFINITY BIOLOGICALS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VisuLize™ Factor VIII Antigen Kit is an Enzyme Immunoassay for the quantitative determination of Factor VIII Antigen in human plasma samples and Factor VIII concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA)
Device Description
The VisuLize™ Factor VIII Antigen kit is a sandwich enzyme-linked immuno-sorbent assay (ELISA) using a polyclonal antibody coated 96-microwell format. Plasma samples are diluted and applied to the pre-coated wells. After washing away unbound proteins, a horseradish peroxidase (HRP) labelled polyclonal antibody is applied to detect the captured Factor VIII. A chromogenic substrate (TMB) is added to allow for color development. The color formed is measured spectrophotometrically at 450 nm, with the absorbance being directly proportional to the concentration of Factor VIII that was in the sample.
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K Number
K051054Device Name
VISULIZE FACTOR IX ANTIGEN KIT
Manufacturer
AFFINITY BIOLOGICALS INC.
Date Cleared
2005-06-29
(64 days)
Product Code
GGP
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
AFFINITY BIOLOGICALS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VisuLize™ Factor IX Antigen Kit is intended for use as an in vitro diagnostic assay for the quantitative determination of Factor IX antigen in human plasma samples and Factor IX concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA).
Device Description
The VisuLize™ Factor IX Antigen kit is a sandwich enzyme-linked immuno-sorbent assay (ELISA) using a polyclonal antibody coated 96-microwell format. Plasma samples are diluted and applied to the pre-coated wells. After washing away unbound proteins, a horseradish peroxidase (HRP) labelled polyclonal antibody is applied to detect the captured Factor IX. A chromogenic substrate (TMB containing H2O2) is added to allow for color development. The color formed is measured spectrophotometrically at 450 nm, with the absorbance being directly proportional to the concentration of Factor IX that was in the sample.
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