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CORGENIX MEDICAL CORPORATION

Last updated May 30, 2026

What CORGENIX MEDICAL CORPORATION makes

Corgenix Medical Corporation manufactures in vitro diagnostic (IVD) test kits for detecting autoantibodies and coagulation factors. These include enzyme immunoassay (EIA) kits for anticardiolipin, anti-beta-2-glycoprotein I, phosphatidylserine, and anti-prothrombin antibodies, as well as chromogenic assays for protein S and protein C, and kits for measuring von Willebrand factor activity and antigen levels, along with coagulation controls.

The devices are classified as Class II medical devices and are listed in the FDA's Unique Device Identification (FDA UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Corgenix Medical Corporation make?

Corgenix Medical Corporation manufactures in vitro diagnostic (IVD) test kits for detecting autoantibodies and coagulation factors, including enzyme immunoassay kits for anticardiolipin, anti-beta-2-glycoprotein I, phosphatidylserine, and anti-prothrombin antibodies, chromogenic assays for protein S and protein C, and kits for measuring von Willebrand factor activity and antigen levels, along with coagulation controls.

Where is Corgenix Medical Corporation based?

Corgenix Medical Corporation is based in the United States, as stated in the provided device data summary.

Which regulatory registries list Corgenix Medical Corporation's devices?

Corgenix Medical Corporation's devices are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated in the LISTED IN field of the device data.

How are Corgenix Medical Corporation's devices classified?

Corgenix Medical Corporation's devices are classified as Class II medical devices, as specified in the DEVICE CLASSES field of the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: corgenix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-729-5661
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 619834542

Catalogue (28)

Device	Model / Reference	Registries	Class	Status
REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (96 Well)	039-001	FDA UDI	Class II	Active
Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody)	11854	FDA UDI	Class II	Unknown
REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit	10238	FDA UDI	Class II	Active
REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well)	10206	FDA UDI	Class II	Active
REAADS Protein S Antigen Test kit	036-001	FDA UDI	Class II	Active
Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well)	13370	FDA UDI	Class II	Active
Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well)	13529	FDA UDI	Class II	Active
REAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well)	038-001	FDA UDI	Class II	Active
REAADS Coagulation Control 1	701-001	FDA UDI	Class II	Active
REAADS von Willebrand Factor Activity Test Kit	10826	FDA UDI	Class II	Active
Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well)	13534	FDA UDI	Class II	Active
REAADS von Willebrand Factor Antigen Test Kit	034-001	FDA UDI	Class II	Active
Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well)	13371	FDA UDI	Class II	Active
REAADS Anti-dsDNA Test Kit	13086	FDA UDI	Class II	Active
11dhTxB2 Test Kit (11-Dehydro Thromboxane B2)	12136	FDA UDI	Class II	Active
Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well)	13535	FDA UDI	Class II	Active
REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well)	030-001	FDA UDI	Class II	Active
REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well)	026-001	FDA UDI	Class II	Active
Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well)	13525	FDA UDI	Class II	Active
REAADS Monoclonal Free Protein S Antigen	051-001	FDA UDI	Class II	Active
REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well)	023-001	FDA UDI	Class II	Active
Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well)	13372	FDA UDI	Class II	Active
Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well)	13536	FDA UDI	Class II	Active
REAADS Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (96 Well)	037-001	FDA UDI	Class II	Active
REAADS Protein C Test Kit	035-001	FDA UDI	Class II	Active
Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well)	13530	FDA UDI	Class II	Active
REAADS Coagulation Control 2	702-001	FDA UDI	Class II	Active
Bgm Galectin-3	001	FDA UDI	Class II	Active

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