gudid Primary ID: 034-001

REAADS von Willebrand Factor Antigen Test Kit (UDI 034-001)

Manufactured by CORGENIX MEDICAL CORPORATION

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The REAADS von Willebrand Factor Antigen Test Kit (Model/Catalog Number: 034-001) is a medical device manufactured by CORGENIX MEDICAL CORPORATION. This product is indexed under FDA Product Code / Category Classification GGP within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 034-001
Product Code / EMDN: GGP
Device Name: INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von WillebrandFactor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY THE TESTVon Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found incirculation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein alsoknown as the anti-hemophilic factor. These two proteins show distinct biochemical and functionalproperties as well as different antigenic determinants; their plasma levels may vary independently ofeach other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes VonWillebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of thegeneral 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 TESTREAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any availableVWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed toremove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradishperoxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unboundconjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogenperoxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in opticaldensity (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percentconcentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert.
Database Sync Date: 2026-08-09 09:49:29

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of REAADS von Willebrand Factor Antigen Test Kit?

The registered manufacturer of record for REAADS von Willebrand Factor Antigen Test Kit is CORGENIX MEDICAL CORPORATION.

What is the Primary UDI-DI identifier for REAADS von Willebrand Factor Antigen Test Kit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 034-001.

What classification code is assigned to this device?

This device is registered under product classification code GGP.

Similar Classification Devices (GGP)

Other Devices by CORGENIX MEDICAL CORPORATION

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint