The VisuCon-F Frozen Normal Plasma is a Normal Reference (Factor Assay Control) Plasma 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. Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration. The VisuCon-F Frozen Normal Control plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02M HEPES buffer, dispensed and rapidly frozen. This Normal Reference (Factor Assay Control) Plasma may be used to monitor the performance of coagulation assays for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin, Protein C, and Protein S.
This product is cleared for in vitro Diagnostic use by FDA, Health Canada and CE marked. Available for sale in the United States, Canada and select European countries.
Box containing 5 x 1 mL vials of frozen plasma, Prod. # FCSN0105
Box containing 25 x 1 mL vials of frozen plasma, Prod. # FCSN0125
Each box of VisuCon-F Frozen Normal Control Plasma contains a lot-specific Certificate of Analysis with the assigned reference ranges for each parameter. The reported reference ranges were determined against, where available, the SSC/ISTH secondary coagulation standard that is traceable to current WHO International Standards.
Preparation/Handling:
Thaw each vial at 37°C (+/- 1°C) in a water bath for 5 minutes. Invert gently before use.
Storage and Stability:
Once thawed, the plasma is stable for 8 hours at 2-8°C in original vial. Thawed material should be discarded after use and not be refrozen.
Assay Procedure:
After thawing the Control Plasma, use on coagulation instrument or assay system with corresponding reagents in accordance with established assay procedures for the quantitative determination of coagulation parameters. Refer to the lot specific Certificate of Analysis for the assigned range for each parameter. The results obtained for the control plasma will depend on various factors including types of reagents, factor deficient substrates and instrumentation therefore it is recommended that each laboratory establish its own mean values and expected reference ranges for quality control purposes using their particular instrument-reagent system.
UFNCP0125 – VisuCon-F Frozen Unassayed Normal Control Plasma – 25 x 1ml box (IVD) UFNCP0181 – VisuCon-F Frozen Unassayed Normal Control Plasma – 81 x 1ml box (IVD) UFNCP0481 – VisuCon-F Frozen Unassayed Normal Control Plasma – 81 x 4ml box (IVD)
Normal Reference (Factor Assay Control) Plasma
FRNCP0105 – VisuCon-F Frozen Normal Control Plasma – 5 x 1ml Box (IVD)
FRNCP0125 – VisuCon-F Frozen Normal Control Plasma – 25 x 1ml Box (IVD)
Description
Normal Reference (Factor Assay Control) Plasma
The VisuCon-F Frozen Normal Plasma is a Normal Reference (Factor Assay Control) Plasma 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. Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration. The VisuCon-F Frozen Normal Control plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02M HEPES buffer, dispensed and rapidly frozen. This Normal Reference (Factor Assay Control) Plasma may be used to monitor the performance of coagulation assays for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin, Protein C, and Protein S.
This product is cleared for in vitro Diagnostic use by FDA, Health Canada and CE marked. Available for sale in the United States, Canada and select European countries.
Each box of VisuCon-F Frozen Normal Control Plasma contains a lot-specific Certificate of Analysis with the assigned reference ranges for each parameter. The reported reference ranges were determined against, where available, the SSC/ISTH secondary coagulation standard that is traceable to current WHO International Standards.
Preparation/Handling:
Thaw each vial at 37°C (+/- 1°C) in a water bath for 5 minutes. Invert gently before use.
Storage and Stability:
Once thawed, the plasma is stable for 8 hours at 2-8°C in original vial. Thawed material should be discarded after use and not be refrozen.
Assay Procedure:
After thawing the Control Plasma, use on coagulation instrument or assay system with corresponding reagents in accordance with established assay procedures for the quantitative determination of coagulation parameters. Refer to the lot specific Certificate of Analysis for the assigned range for each parameter. The results obtained for the control plasma will depend on various factors including types of reagents, factor deficient substrates and instrumentation therefore it is recommended that each laboratory establish its own mean values and expected reference ranges for quality control purposes using their particular instrument-reagent system.
Product Datasheet: VisuCon-F Normal Control Plasma
Related Products:
Frozen Factor X Deficient Plasma
View Product
FRDP100105 – VisuDep-F Frozen Factor X deficient plasma – 5 x 1ml Box (IVD)
FRDP100125 – VisuDep-F Frozen Factor X deficient plasma – 25 x 1ml Box (IVD)
Frozen Factor VII Deficient Plasma
View Product
FRDP070105 – VisuDep-F Frozen Factor VII deficient plasma – 5 x 1ml Box (IVD)
FRDP070125 – VisuDep-F Frozen Factor VII deficient plasma – 25 x 1ml Box (IVD)
Normal Reference (Factor Assay Control) Plasma
View Product
FRNCP0105 – VisuCon-F Frozen Normal Control Plasma – 5 x 1ml Box (IVD)
FRNCP0125 – VisuCon-F Frozen Normal Control Plasma – 25 x 1ml Box (IVD)
Hemostasis Control Plasma (Mid-Level Abnormal)
View Product
LCSAB101 – VisuCon-L Coag Screen ABN1 – 10 x 1ml Box (IVD)
Fibrinogen Control Plasma
View Product
LFGCP0105 – VisuCon-F Low Fibrinogen Control Plasma – 5 x 1ml Box (IVD)
LFGCP0125 – VisuCon-F Low Fibrinogen Control Plasma – 25 x 1ml Box (IVD)
LFGCP0181 – VisuCon-F Low Fibrinogen Control Plasma – 81 x 1ml Box (IVD)
Abnormal Reference (Factor Assay Control) Plasma
View Product
FRABP0105 – VisuCon-F Frozen Abnormal Control Plasma – 5 x 1ml Box (IVD)
FRABP0125 – VisuCon-F Frozen Abnormal Control Plasma – 25 x 1ml Box (IVD)
Abnormal Hemostasis Control Plasma
View Product
UFAB10125 – VisuCon-F Frozen Unassayed Abnormal Control Plasma – 25 x 1ml box (IVD)
UFAB10181 – VisuCon-F Frozen Unassayed Abnormal Control Plasma – 81 x 1ml box (IVD)
UFAB10481 – VisuCon-F Frozen Unassayed Abnormal Control Plasma – 81 x 4ml box (IVD)
Hemostasis Control Plasma – Normal
View Product
LCSN01 – VisuCon-L Coag Screen N – 10 x 1ml box (IVD)
Frozen Factor VIII Deficient Plasma
View Product
FRDP080105 – VisuDep-F Frozen Factor VIII deficient plasma – 5 x 1ml Box (IVD)
FRDP080125 – VisuDep-F Frozen Factor VIII deficient plasma – 25 x 1ml Box (IVD)
Normal Reference – Calibrator Plasma
View Product
FRSP0125 – VisuCal-F Frozen Calibrator Plasma – 25 x 1ml Box (IVD)
FRSP0105 – VisuCal-F Frozen Calibrator Plasma – 5 x 1ml Box (IVD)
Frozen Factor XI Deficient Plasma
View Product
FRDP110105 – VisuDep-F Frozen Factor XI deficient plasma – 5 x 1ml Box (IVD)
FRDP110125 – VisuDep-F Frozen Factor XI deficient plasma – 25 x 1ml Box (IVD)
Frozen Factor II Deficient Plasma
View Product
FRDP020105 – VisuDep-F Frozen Factor II deficient plasma – 5 x 1ml Box (IVD)
FRDP020125 – VisuDep-F Frozen Factor II deficient plasma – 25 x 1ml Box (IVD)
Frozen Normal Pooled Plasma
View Product
UFNCP0125 – VisuCon-F Frozen Unassayed Normal Control Plasma – 25 x 1ml box (IVD)
UFNCP0181 – VisuCon-F Frozen Unassayed Normal Control Plasma – 81 x 1ml box (IVD)
UFNCP0481 – VisuCon-F Frozen Unassayed Normal Control Plasma – 81 x 4ml box (IVD)
Hemostasis Control Plasma (High-Level Abnormal)
View Product
LCSAB101 – VisuCon-L Coag Screen ABN2 – 10 x 1ml Box (IVD)
Routine Normal Control Plasma
View Product
FCSN0125 – VisuCon-F Frozen Coag Screen N – 25 x 1ml box (IVD)
FCSN0181 – VisuCon-F Frozen Coag Screen N – 81 x 1ml box (IVD)
FCSN0481 – VisuCon-F Frozen Coag Screen N – 81 x 4ml box (IVD)
Routine Abnormal Control Plasma
View Product
FCSAB0125 – VisuCon-F Frozen Coag Screen ABN – 25 x 1ml box (IVD)
FCSAB0181 – VisuCon-F Frozen Coag Screen ABN – 81 x 1ml box (IVD)
FCSAB0481 – VisuCon-F Frozen Coag Screen ABN – 81 x 4ml box (IVD)
Frozen Factor V Deficient Plasma
View Product
FRDP050105 – VisuDep-F Frozen Factor V deficient plasma – 5 x 1ml Box (IVD)
FRDP050125 – VisuDep-F Frozen Factor V deficient plasma – 25 x 1ml Box (IVD)
Frozen Factor XII Deficient Plasma
View Product
FRDP120105 – VisuDep-F Frozen Factor XII deficient plasma – 5 x 1ml Box (IVD)
FRDP120125 – VisuDep-F Frozen Factor XII deficient plasma – 25 x 1ml Box (IVD)
Frozen Factor IX Deficient Plasma
View Product
FRDP090105 – VisuDep-F Frozen Factor IX deficient plasma – 5 x 1ml Box (IVD)
FRDP090125 – VisuDep-F Frozen Factor IX deficient plasma – 25 x 1ml Box (IVD)