Ventrex Laboratories, Inc.

United StatesFDA applicant, unverified

Devices: 82

What Ventrex Laboratories, Inc. makes

Ventrex Laboratories, Inc. manufactures in vitro diagnostic (IVD) test kits and reagents for clinical laboratory use, including immunoassays for hormones (e.g., HCG, TSH, T3 uptake), allergens, and infectious agents (e.g., Streptococcus A). Their portfolio also covers radioimmunoassay (RIA) and enzyme-linked immunosorbent assay (EIA) controls, as well as microvial test sets for biochemical markers like ACE activity and vitamin B12/folate levels.

The company’s products are regulated under FDA’s 510(k) clearance process, with devices classified as Class I (general controls) and Class II (special controls). These tests are listed in the FDA’s 510(k) registry, reflecting their authorised status for clinical diagnostic use in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Ventrex Laboratories, Inc.

What Ventrex Laboratories, Inc. makes

Catalogue82

Ventre/Zyme Ige Kit Ref K831485

Ria Ssist Ti-59 Magnetic Card Programs Ref K822860

Ventrex Allergen Disc Ref K913833

Ventrex Ip Specific E Enzyme Immunoassay Ref K870624

Centria Cortisol Ria Test Set Ref K792243

Ventre/Sep Ref K811423

Ventre/Sep T3 Test Set Ref K791588

Ventresign Strep A Test Ref K897083

Ventrescreen, Hcg Urine Ref K874258

Riassist Rast Data Reduction/Quality Ref K830170

Ventrezyme Phenytoin Kit Immunoassay Ref K842161

Ventrex Enzyme Tsh Kit Ref K830928

Free T4 Ria Test Set Ref K813465

Centria Prolactin Test Set Ref K813572

Coated Tube High Sensitivity Tsh 100 Uiu/Ml Stan. Ref K895648

Ventre/Sep Ige Ria Test Set Ref K811559

Ventre/Spec Allergen Control-Molds/Food Ref K820977

Angiotensin Converting Enzyme Assay Sys Ref K791712

Ventre/Sep T3 Uptake Radioassay Ref K800165

Ventre/Spec Allergen Control-Inhalant Ref K820978

Ventre/Sep Ferritin Ria Ref K790447

Ventre/Sep Digoxin Radioimmunoassay Kit Ref K791355

Ventrescreen Capillary Blood Collection Tube Ref K873647

Ventrex Apo B Ref K861919

Ventrescreen Cat/Dog Allergy Test Kit Enzyme Immu. Ref K871331

Ventrezyme Allergen Data Reduction System Ref K851403

Nein Allergen Disc In Vast Ventrex Test Ref K831554

Shbg Irma Kit Ref K905247

New Allergen Disc -Vast Ventex Allergy Ref K831091

Ventrezyme Phenobarbital Kit Immuno Ref K842264

Ventre/Spec Allergen Control-Molds/Food Ref K832217

Hl-1 Supplement Ref K870876