Home GUDID 00855360006007
REAADS Protein S Antigen Test kit
Primary DI 00855360006007
Brand REAADS Protein S Antigen Test kit
Company CORGENIX MEDICAL CORPORATION
Model 036-001
Catalog number 036-001
Device description INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE PROTEIN S TESTProtein 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, downregulating 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 (
Published 2016-07-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name GGP Test, Qualitative And Quantitative Factor Deficiency
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GGP Test, Qualitative And Quantitative Factor Deficiency Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00855360006007 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00855360006007 00855360006007 855360006007 0855360006007
GMDN Terms# Term, Definition table Term Definition Protein S IVD, kit, chromogenic A collection of reagents and other associated materials intended to be used for the quantitative measurement of protein S in a clinical specimen, using a chromogenic method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 619834542 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00855360006243 REAADS Coagulation Control 1 701-001 701-001 2016-07-14 00855360006250 REAADS Coagulation Control 2 702-001 702-001 2016-07-14 00867444000207 BGM GALECTIN-3 001 2016-07-26 00855360006014 REAADS Monoclonal Free Protein S Antigen 051-001 051-001 2016-07-14 00855360006021 REAADS Protein C Test Kit 035-001 035-001 2016-05-26 00855360006038 REAADS von Willebrand Factor Antigen Test Kit 034-001 034-001 2016-07-14 00855360006069 Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well) 13525 13525 2016-07-14 00855360006076 Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well) 13529 13529 2016-07-14 00855360006083 Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well) 13530 13530 2016-07-14 00855360006113 Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well) 13534 13534 2016-07-14 00855360006120 Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well) 13536 13536 2016-07-14 00855360006137 Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well) 13535 13535 2016-07-14 00855360006175 Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well) 13370 13370 2016-07-14 00855360006182 Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) 13371 13371 2016-07-14 00855360006199 Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) 13372 13372 2016-07-14 00855360006236 Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) 11854 11854 2016-08-08 00855360006267 REAADS von Willebrand Factor Activity Test Kit 10826 10826 2016-07-14 00855360006274 11dhTxB2 Test Kit (11-Dehydro Thromboxane B2) 12136 12136 2016-08-08 00855360006045 REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well) 023-001 023-001 2016-07-14 00855360006052 REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well) 026-001 026-001 2016-07-14
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