The VisuCon-F Frozen Coag Screen Normal is a Routine Normal 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 Coag Screen N 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 Routine Normal Control Plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
This product is cleared for in vitro Diagnostic use by FDA and is available for sale in the United States only. This product is not available in Canada or select European countries – see VisuCon-F Unassayed Normal Control Plasmafor a Routine Normal Control Plasma that is available in Canada and select European countries.
Box containing 25 x 1 mL vials of frozen plasma, Prod. # FCSN0125
Each box of VisuCon-F Frozen Coag Screen Normal contains a lot-specific Certificate of Analysis. The results presented in the supplied Certificate of Analysis were determined from data specific to the instrument-reagent system used for internal quality control testing. Lot specific results may vary when using different instrument and reagent combinations.
Preparation/Handling:
Thaw each vial at 37°C (+/- 1°C) in a water bath for 5 minutes. Invert gently before use.
Storage and Stability:
Vials are stable until the expiration date stated on the vial when stored at –60°C or lower. Once thawed, the plasma is stable for 8 hours on-board (15 – 22°C) or at 2-8°C in original vial. Thawed material should be discarded after use and not be refrozen.
Assay Procedure:
After thawing the VisuCon-F Frozen Coag Screen N plasma, use on coagulation instrument or assay system with corresponding reagents in accordance with established coagulation assay procedures. Each laboratory should establish and maintain its own quality control ranges for each particular instrument-reagent system used. If appropriate control values are not obtained, assess the components of the assay system including reagents, substrate plasmas, calibrator plasma or instrumentation to identify potential sources of error. QC materials should be used in accordance with local, state, and/or federal regulations or accreditation requirements.
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)
Routine Normal Control Plasma
FCSN0125 – VisuCon-F Frozen Coag Screen N – 25 x 1ml box (IVD)
Description
Routine Normal Control Plasma
The VisuCon-F Frozen Coag Screen Normal is a Routine Normal 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 Coag Screen N 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 Routine Normal Control Plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
This product is cleared for in vitro Diagnostic use by FDA and is available for sale in the United States only. This product is not available in Canada or select European countries – see VisuCon-F Unassayed Normal Control Plasma for a Routine Normal Control Plasma that is available in Canada and select European countries.
Each box of VisuCon-F Frozen Coag Screen Normal contains a lot-specific Certificate of Analysis. The results presented in the supplied Certificate of Analysis were determined from data specific to the instrument-reagent system used for internal quality control testing. Lot specific results may vary when using different instrument and reagent combinations.
Preparation/Handling:
Thaw each vial at 37°C (+/- 1°C) in a water bath for 5 minutes. Invert gently before use.
Storage and Stability:
Vials are stable until the expiration date stated on the vial when stored at –60°C or lower. Once thawed, the plasma is stable for 8 hours on-board (15 – 22°C) or at 2-8°C in original vial. Thawed material should be discarded after use and not be refrozen.
Assay Procedure:
After thawing the VisuCon-F Frozen Coag Screen N plasma, use on coagulation instrument or assay system with corresponding reagents in accordance with established coagulation assay procedures. Each laboratory should establish and maintain its own quality control ranges for each particular instrument-reagent system used. If appropriate control values are not obtained, assess the components of the assay system including reagents, substrate plasmas, calibrator plasma or instrumentation to identify potential sources of error. QC materials should be used in accordance with local, state, and/or federal regulations or accreditation requirements.
Product Datasheet: VisuCon-F Coag Screen N - Routine Frozen Normal Pooled Plasma NPP
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