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Seradyn, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
30
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Seradyn, Inc. makes

Seradyn, Inc. manufactures in vitro diagnostic reagents, assays, calibrators, and controls for therapeutic drug monitoring and clinical chemistry. Their product portfolio includes assays for valproic acid, lamotrigine, digoxin, theophylline, zonisamide, gentamicin, and vancomycin, as well as ferritin assays, rubella tests, and electrophoresis controls.

The company is based in the United States and produces devices classified as Class I and Class II. These products are listed in the FDA 510(k) regulatory registry.

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

Catalogue30

Newest first, rows 1-30 of 30

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Rows 1-30 of 30

FDA recalls1

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

FDA recall records list 1 recall initiated by Seradyn, Inc., initiated on 2007-12-20. By recorded status: 1 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.

  • 2007

    • 20 Dec 2007 Z-1102-2008 Unclassified (pre-2012) Terminated False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results. Distribution: Worldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada,…
      Full distribution text Worldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada, Finland, Germany, Ireland, Japan, Spain and United Kingdom.
      Submission number: K050419

Frequently asked questions

How many devices does Seradyn, Inc. have in the registry?

The registry currently lists 30 devices for Seradyn, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Seradyn, Inc.'s devices?

Among its 30 most recently registered devices, Seradyn, Inc. has devices listed in FDA 510(k) (30 devices).

What risk classes do Seradyn, Inc.'s devices fall under?

Among its 30 most recently registered devices, the classes recorded for Seradyn, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Seradyn, Inc.?

FDA recall records list 1 recall initiated by Seradyn, Inc., the most recent initiated on 2007-12-20. 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 Seradyn, Inc. in the registry?

The most recently registered devices listed for Seradyn, Inc. include QMS QUINIDINE. QMS QUINIDINE CALIBRATORS, REAGENT A AND REAGENT B, QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 and LPIA-FERRITIN ASSAY.

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