Skip to content

Sekisui Diagnostics P.E.I., Inc.

CanadaFDA applicant, unverified FDA

Devices
6
Registrations
FDA
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Sekisui Diagnostics P.E.I., Inc. makes

Sekisui Diagnostics P.E.I., Inc. manufactures in vitro diagnostic assays for clinical laboratory use, including quantitative measurements for acetaminophen, magnesium, creatine kinase, and hemoglobin A1c (HbA1c). The portfolio also covers urine immunoassay calibrators for acetaminophen detection.

These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s 510(k) database and are based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

  • Dc-Uibc-Cal Ref K163078

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • SEKURE Acetaminophen L3K Assay Ref K180835

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Magnesium Assay Ref K111915

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • SEKURE HbA1c Assay Ref K173206

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Acetaminophen Ref K202644

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • SEKURE Creatine Kinase Assay Ref K182702

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Sekisui Diagnostics P.E.I., Inc., the earliest on 2016-01-22 and the most recent on 2016-11-29. By recorded status: 2 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2016

    • 29 Nov 2016 Z-1078-2017 Class II Terminated Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range. Distribution: Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria,…
      Full distribution text Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
      Submission number: K033921
    • 22 Jan 2016 Z-1171-2016 Class II Terminated Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover Distribution: Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the…
      Full distribution text Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
      Submission number: K081938

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Sekisui Diagnostics P.E.I. Inc. CHARLOTTETOWN Prince Edward Island · CA FEI 3002806809

Frequently asked questions

How many devices does Sekisui Diagnostics P.E.I., Inc. have in the registry?

The registry currently lists 6 devices for Sekisui Diagnostics P.E.I., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sekisui Diagnostics P.E.I., Inc.'s devices?

Among its 6 most recently registered devices, Sekisui Diagnostics P.E.I., Inc. has devices listed in FDA 510(k) (6 devices).

What risk classes do Sekisui Diagnostics P.E.I., Inc.'s devices fall under?

Among its 6 most recently registered devices, the classes recorded for Sekisui Diagnostics P.E.I., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sekisui Diagnostics P.E.I., Inc.?

FDA recall records list 2 recalls initiated by Sekisui Diagnostics P.E.I., Inc., the most recent initiated on 2016-11-29. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sekisui Diagnostics P.E.I., Inc. in the registry?

The most recently registered devices listed for Sekisui Diagnostics P.E.I., Inc. include DC-UIBC-CAL, SEKURE Acetaminophen L3K Assay, MAGNESIUM ASSAY and SEKURE HbA1c Assay.

Which FDA establishments are linked to Sekisui Diagnostics P.E.I., Inc.?

1 FDA establishment is linked to Sekisui Diagnostics P.E.I., Inc. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.