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Pooled Normal Plasma

Normal Factor Activity

Pooled Normal Plasma (PNP) contains plasma from 30 or more carefully screened normal human donors. Our PNP is plaet poor with no buffers or preservatives making it most like your patient plasma. An approximay equal number of male and female donors are included. A Certificate of Analysis (CofA) accompanies each shipment of PNP. This lot specific CofA certifies the normalcy of this plasma satisfying regulatory guidelines. Assay values are assigned and reported on the CofA for Prothrombin Time (PT) and activated Partial Thromboplastin Time (aPTT). Fibrinogen and Factors II, V, VII, VIII, IX, X, XI and XII are assayed and certified to be within the normal range. This product is registered with the FDA as in in vitro diagnostic product and can be used without limitations.

Uses:

·         Mixing studies

·         Control for coagulation factor assays

·         Control for specialty coagulation/thrombosis testing

·         Negative control for lupus anticoagulant testing

·         Base plasma for preparing heparin spiked samples

Primary advantages of PNP:

·         Most like patient plasma

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         Certified Normal

·         FDA Registered — Use without limitation

 

FACT – Factor Assay Control Plasma

FACT is Pooled Normal Plasma with assigned assay values for a wide variety of tests. This product includes plasma from 30 or more carefully screened normal human donors. An approximay equal number of male and female donors are included. Values are published for PT, aPTT, Thrombin Time, , Fibrinogen (Clauss) and Fibrinogen Antigen, Factors II, V, VII, VIII, IX, X, XI, XII, ATIII Antigen, ATIII Activity, vWF Antigen, vWF Activity, Protein C Antigen, Protein C Functional, Protein S Functional, Protein S Antigen and Plasminogen. This product is registered with the FDA as an in vitro diagnostic product and can be used without limitations.

Uses for FACT:

·         Standard/Calibrator for coagulation factor assays

·         Assayed control for coagulation factor assays

·         Assayed control for coagulation/thrombosis specialty assays

·         Mixing studies

·         Negative control for lupus anticoagulant testing

·         Base plasma for preparing heparin spiked samples

Primary advantages of FACT:

·         Most like patient plasma

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         Comprehensive coagulation/thrombosis control

·         FDA Registered – use without limitation

Important Note:

Using FACT with B-FACT (Borderline Factor Assay Control) and A-FACT (Abnormal Factor Assay Control) provides effective monitoring of all three sections of the factor assay standard curve.

 

 

B-FACT – Borderline Factor Assay Control Plasma

B-FACT is a borderline factor assay control designed to assess the sensitivity of the mid range section of the standard curve. Lot specific assigned assay values for a wide variety of tests are included with each shipment. Published assay values include PT, APTT, Fibrinogen (Clauss), Fibrinogen Antigen, Factors II, V, VII, VIII, IX, X, XI, XII, ATIII Antigen, ATIII Activity, vWF:Antigen, vWF:Activity, Protein C Antigen, Protein C Functional, Protein S Functional, Protein S Antigen and Plasminogen.This product is registered with the FDA as an in vitro diagnostic product and can be used without limitations.

Uses for B-FACT:

·         Mid range borderline coagulation factor assay control

·         Mid range borderline control for coagulation/thrombosis specialty assays

Primary advantages of B-FACT:

·         Most like patient plasma

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         Comprehensive coagulation/thrombosis control

·         FDA Registered

 

 

A-FACT – Abnormal Factor Assay Control Plasma

A-FACT is an abnormal factor assay control designed to assess the sensitivity of the lower section of the standard curve. Lot specific assigned assay values for a wide variety of tests are included with each shipment. Published assay values include PT, APTT, Thrombin Time, Fibrinogen (Clauss) , Fibrinogen Antigen, Factors II, V, VII, VIII, IX, X, XI, XII, ATIII Antigen, ATIII Activity, vWF:Antigen, vWF:Activity, Protein C Antigen, Protein C Functional, Protein S Functional, Protein S Antigen and Plasminogen. This product is registered with the FDA as an in vitro diagnostic product and can be used without limitations.

Uses for A-FACT:

·         Abnormal control for coagulation factor assays

·         Abnormal control for coagulation and thrombosis specialty assays

Primary advantages of A-FACT:

·         Most like patient plasma

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         Comprehensive coagulation/thrombosis control

·         FDA Registered

Important Note:

Using A-FACT with FACT (Normal Factor Assay Control) and B-FACT (Borderline Factor Assay Control) provides effective monitoring of the factor assay standard curve.

上海金畔生物科技有限公司