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Genetic Testing Institute

Country not established

Devices
6
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Genetic Testing Institute makes

The Genetic Testing Institute develops and provides laboratory-based immunoassay tests for detecting antibodies related to blood clotting disorders and immune responses. Their portfolio includes assays for PF4-dependent antibodies, Factor VIII inhibitors, and immunoglobulin-based screening tests, primarily used in hematology and coagulation diagnostics.

These devices are classified under FDA’s Class I and Class II regulatory categories, with some listed via the 510(k) pathway. The company’s products are authorized for use in the United States under applicable FDA regulations.

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

Catalogue6

Newest first, rows 1-6 of 6

  • PF4 Igg Ref K071781

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

  • Gti-Fviii Inhibitor Assay Ref K993553

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

  • PF4 Enhanced Solid Phase Elisa Ref K053559

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

  • Gti-PF4 Elisa Ref K983379

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

  • Factor Viii Antibody Screen Ref K082205

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

  • Allo-Type Human Immunoglobulin- Ref K841114

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

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Genetic Testing Institute, the earliest on 2013-02-04 and the most recent on 2014-12-15. By recorded status: 2 terminated. The reasons filed fall into these groups: performance or accuracy and manufacturing or quality process. 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.

  • 2014

    • 15 Dec 2014 Z-1001-2015 Class II Terminated Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay. Distribution: Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA,…
      Full distribution text Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )
      Submission number: K053559

  • 2013

    • 4 Feb 2013 Z-1022-2013 Class II Terminated Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain. Submission number: K053559

Frequently asked questions

How many devices does Genetic Testing Institute have in the registry?

The registry currently lists 6 devices for Genetic Testing Institute. Devices recorded under merged duplicate company entries are counted once.

Which registries list Genetic Testing Institute's devices?

Among its 6 most recently registered devices, Genetic Testing Institute has devices listed in FDA 510(k) (6 devices).

What risk classes do Genetic Testing Institute's devices fall under?

Among its 6 most recently registered devices, the classes recorded for Genetic Testing Institute's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Genetic Testing Institute?

FDA recall records list 2 recalls initiated by Genetic Testing Institute, the most recent initiated on 15 Dec 2014. 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 Genetic Testing Institute in the registry?

The most recently registered devices listed for Genetic Testing Institute include PF4 IGG, GTI-FVIII INHIBITOR ASSAY, PF4 ENHANCED SOLID PHASE ELISA and GTI-PF4 ELISA.

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