The VisuCon-L Coag Screen N plasma is a Hemostasis Control Plasma – Normal 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. This Hemostasis Control Plasma – Normal may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents. Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration. This plasma is citrated human Pooled Normal Plasma – PNP collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer, as well as stabilizing agents, dispensed and lyophilized.
VisuCon-L Coag Screen N 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 10 x 1 mL vials of lyophilized plasma, Prod. # LCSN01
The results obtained with the VisuCon-L Coag Screen N plasma will be subject to the limitations of the assay system including types of reagents and instrumentation.
Preparation/Handling:
Reconstitute each vial with 1 ml reagent grade water. Swirl gently and let stand for 15 minutes. Swirl gently once more before use.
Storage and Stability:
Vials are stable until the expiration date stated on the vial when stored at 2 – 8°C. Once reconstituted, the plasma is stable for 24 hours on-board (15 – 22°C) or at 2 – 8°C in original vial. Gently mix vial of plasma if left for more than 2 hours without use. Reconstituted material should be discarded after use and not be refrozen.
Assay Procedure:
After reconstituting the VisuCon-L Coag Screen N plasma, use on coagulation instrument or assay system with corresponding reagents in accordance with established coagulation assay procedures. If appropriate control values are not obtained, assess the components of the assay system including reagents, substrate plasmas, calibrator plasma or instrumentation to try and identify potential sources of error.
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)
Hemostasis Control Plasma – Normal
LCSN01 – VisuCon-L Coag Screen N – 10 x 1ml box (IVD)
Description
Hemostasis Control Plasma – Normal
The VisuCon-L Coag Screen N plasma is a Hemostasis Control Plasma – Normal 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. This Hemostasis Control Plasma – Normal may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents. Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration. This plasma is citrated human Pooled Normal Plasma – PNP collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer, as well as stabilizing agents, dispensed and lyophilized.
VisuCon-L Coag Screen N 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.
The results obtained with the VisuCon-L Coag Screen N plasma will be subject to the limitations of the assay system including types of reagents and instrumentation.
Preparation/Handling:
Reconstitute each vial with 1 ml reagent grade water. Swirl gently and let stand for 15 minutes. Swirl gently once more before use.
Storage and Stability:
Vials are stable until the expiration date stated on the vial when stored at 2 – 8°C. Once reconstituted, the plasma is stable for 24 hours on-board (15 – 22°C) or at 2 – 8°C in original vial. Gently mix vial of plasma if left for more than 2 hours without use. Reconstituted material should be discarded after use and not be refrozen.
Assay Procedure:
After reconstituting the VisuCon-L Coag Screen N plasma, use on coagulation instrument or assay system with corresponding reagents in accordance with established coagulation assay procedures. If appropriate control values are not obtained, assess the components of the assay system including reagents, substrate plasmas, calibrator plasma or instrumentation to try and identify potential sources of error.
Product Datasheet: Pooled Normal Plasma PNP - VisuCon-L Coag Screen N
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