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REAADS von Willebrand Factor Antigen Test Kit

FDA UDI

Class II (US FDA UDI)

by Corgenix Medical Corporation

Identity

Trade Name
REAADS von Willebrand Factor Antigen Test Kit FDA UDI
Generic Name
Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand Factor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY THE TEST Von Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found in circulation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein also known as the anti-hemophilic factor. These two proteins show distinct biochemical and functional properties as well as different antigenic determinants; their plasma levels may vary independently of each other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes Von Willebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of the general population. Approximately 80% of Von Willebrand disease patients have a type I deficiency. The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative (functional) determinations. PRINCIPLE OF THE TEST REAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available VWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed to remove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradish peroxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert. FDA UDI
Model / Reference
034-001 FDA UDI
Description
INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand Factor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY THE TEST Von Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found in circulation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein also known as the anti-hemophilic factor. These two proteins show distinct biochemical and functional properties as well as different antigenic determinants; their plasma levels may vary independently of each other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes Von Willebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of the general population. Approximately 80% of Von Willebrand disease patients have a type I deficiency. The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative (functional) determinations. PRINCIPLE OF THE TEST REAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available VWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed to remove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradish peroxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert. FDA UDI

Identifiers

Catalog Number
034-001 FDA UDI
Primary DI / UDI-DI
00855360006038 FDA UDI
510(k) Number
K972005 FDA UDI
FDA Product Code
GGP FDA UDI
GMDN Term
Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA) 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)

REAADS von Willebrand Factor Antigen Test Kit by Corgenix Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K972005 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corgenix Medical Corporation

Sources (1)

  • FDA UDI 3ad402d2-01c4-4755-9366-e9d5973bd444 37 fields · synced May 30, 2026