REAADS Protein S Antigen Test kit

FDA UDI

Class II (US FDA UDI)

by Corgenix Medical Corporation

Identity

Trade Name: REAADS Protein S Antigen Test kit FDA UDI
Generic Name: Protein S IVD, kit, chromogenic FDA UDI
Device Name: INTENDED USE An 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 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, 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 (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%.7 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.8 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. FDA UDI
Model / Reference: 036-001 FDA UDI
Description: INTENDED USE An 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 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, 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 (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%.7 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.8 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. FDA UDI

Identifiers

Catalog Number: 036-001 FDA UDI
Primary DI / UDI-DI: 00855360006007 FDA UDI
510(k) Number: K972482 FDA UDI
FDA Product Code: GGP FDA UDI
GMDN Term: Protein S IVD, kit, chromogenic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7290 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Protein S IVD, kit, chromogenic

REAADS Protein S Antigen Test kit by Corgenix Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Protein S IVD, kit, chromogenic.

REAADS Monoclonal Free Protein S Antigen — CORGENIX MEDICAL CORPORATION · Class II

Cleared under the same submission

K972482 also covers:

Protein S ELISA Kit — Helena Laboratories, Corp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Corgenix Medical Corporation

Sources (1)

FDA UDI 6e9ca558-82d9-4c25-8c72-c2771649db7a 37 fields · synced Jun 1, 2026