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Arlington Scientific, Inc.

United States·US-MF-000057059

Last updated September 17, 2026

About

Arlington Scientific is an industry leading global medical technology company. We develop and manufacture in-vitro diagnostic test kits, non-mammalian blocking buffers, the ASI Evolution Automated RPR Syphilis Analyzer, nasal curettes for rapid viral testing, and blood donor lounges.

From the manufacturer's own website. Source

What Arlington Scientific, Inc. makes

The company produces in-vitro diagnostic (IVD) test kits and reagents for detecting antibodies and antigens in clinical samples, including syphilis (Treponema pallidum reagin), Staphylococcus aureus, C-reactive protein (CRP), Group A Streptococcus, Epstein-Barr virus (EBV), systemic lupus erythematosus (SLE)-associated antibodies, rubella virus, and rheumatoid factor. Products include agglutination-based kits, precipitation/immunodiffusion assays, and rapid agglutination tests, as well as disposable test cards and control sets for laboratory use.

These devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) and UDI databases. The manufacturer 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
1840 North Technology Drive, Springville, United States
Phone
801-489-8911
PRRC Contact
Ryan Brimhall
EUDAMED SRN
US-MF-000057059
FDA FEI Number
1641328
DUNS Number
—

Catalogue (159)

Page 4 of 4
DeviceModel / ReferenceRegistriesClassStatus
ASI Mumps IgG EIA Test NC-860096-AG
FDA UDI
Class IActive
ASI RPR Card Test for Syphilis NC-987510LCA
FDA UDI
Class IIActive
ASI RF Direct Slide Test NC-700100DC
FDA UDI
Class IIActive
ASI Infinity Analyzer NC-2700-000
FDA UDI
Class IActive
ASI RPR Card Test for Syphilis NC-900100
FDA UDI
Class IIActive
ASI Evolution K173376
FDA 510(k)
Class IIActive
Asimanager - At K111356
FDA 510(k)
Class IActive
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer K201438
FDA 510(k)
Class IIActive
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution K182391
FDA 510(k)
Class IIActive

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