REAADS Monoclonal Free Protein S Antigen 051-001

GUDID 00855360006014

INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE PROTEIN S TEST Protein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, down-regulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not. Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%. Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia, and various inflammatory syndromes. A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule. Refer to Product Package Insert.

CORGENIX MEDICAL CORPORATION

Protein S IVD, kit, chromogenic
Primary Device ID00855360006014
NIH Device Record Keyb4dbc5be-c3ed-4118-aa13-e52753bee401
Commercial Distribution StatusIn Commercial Distribution
Brand NameREAADS Monoclonal Free Protein S Antigen
Version Model Number051-001
Catalog Number051-001
Company DUNS619834542
Company NameCORGENIX MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-729-5661
Emailtechnicalsupport@corgenix.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855360006014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGPTest, Qualitative And Quantitative Factor Deficiency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-14

Devices Manufactured by CORGENIX MEDICAL CORPORATION

00855360006007 - REAADS Protein S Antigen Test kit2018-07-06 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen
00855360006014 - REAADS Monoclonal Free Protein S Antigen2018-07-06INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE PROTEIN S TEST Protein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, down-regulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not. Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (
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