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Diagnostic Automation/ Cortez Diagnostics, Inc.

United States·US-MF-000051963

Last updated September 18, 2026

About

Diagnostics Automation / Cortez Diagnostics, Inc. is a global leader in diagnostic innovation. Founded in 1989, the company reaches 168 countries with its broad diagnostic test kits. These products include ELISA kits, Rapid Tests, Chemiluminescence kits, Serology kits, IFA kits, and Instruments. Diagnostic Automation / Cortez Diagnostics, Inc. is recognized for its high-quality and reliable products, fast shipping, competitive prices and commitment to excellence in customer care. Our team is dedicated to fulfilling all orders in their entirety. Diagnostic Automation / Cortez Diagnostics, Inc. is a privately owned corporation located at 21250 Califa St., Suite 102 & 116, Woodland Hills, California, 91367, USA.

From the manufacturer's own website. Source

What Diagnostic Automation/ Cortez Diagnostics, Inc. makes

The company manufactures enzyme-linked immunosorbent assay (ELISA) kits for measuring folate, vitamin B12, and ferritin levels in blood samples. It also produces immunoassay kits for detecting human-specific immunoglobulin E (IgE) and immunoglobulin G (IgG) antibodies, including panels for seasonal allergens, perennial allergens, atopic allergens, and 88 food allergens.

These in vitro diagnostic (IVD) products fall under the general IVD class and are registered in the EU’s eudamed database. 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.

Information

Country
United States
Address
21250 Califa St, WOODLAND HILLS, United States
LinkedIn
—
Phone
+1 8185913030
PRRC Contact
Marcia Muller
EUDAMED SRN
US-MF-000051963
FDA FEI Number
—
DUNS Number
—

Catalogue (8)

DeviceModel / ReferenceRegistriesClassStatus
AccuDiag™ Folate ELISA 3127-15
EUDAMED
IVD GeneralActive
AccuDiag™ Human Specific IgE (20 Seasonal Allergens) 5150-8
EUDAMED
IVD GeneralActive
AccuDiag™ Human Specific IgE (20 Perennial Allergens) 5253-8
EUDAMED
IVD GeneralActive
AccuDiag™ Vitamin B12 ELISA 3125-15
EUDAMED
IVD GeneralActive
AccuDiag™ Human Specific IgG 88 Food Allergens 5154-8
EUDAMED
IVD GeneralActive
AccuDiag™ Ferritin ELISA 1601-18
EUDAMED
IVD GeneralActive
AccuDiag™ Human Specific IgE (20 Atopic Allergens) 5151-8
EUDAMED
IVD GeneralActive
AccuDiagTM Total Human IgE 1801-18
EUDAMEDFDA UDI
IVD GeneralActive

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