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Medical Diagnostic Technologies, Inc.

United StatesFDA applicant, unverified

Devices
57

What Medical Diagnostic Technologies, Inc. makes

Medical Diagnostic Technologies, Inc. manufactures in vitro diagnostic reagents and controls, including systems for measuring aspartate aminotransferase and creatine kinase, as well as plasma-based controls for coagulation testing (e.g., APTT, Factor VII/VIII deficiency). The company also produces antibody test systems for Borrelia burgdorferi (IgM) and platelet aggregation reagents, alongside specialized assay controls like ristocetin cofactor and heparin control plasma.

The portfolio includes Class I and Class II devices, with submissions recorded in the FDA’s 510(k) registry. These products are intended for laboratory use in clinical chemistry, immunodiagnostics, and hematology. The company is based in the United States.

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

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Frequently asked questions

How many devices does Medical Diagnostic Technologies, Inc. have in the registry?

The registry currently lists 57 devices for Medical Diagnostic Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medical Diagnostic Technologies, Inc.'s devices?

Among its 50 most recently registered devices, Medical Diagnostic Technologies, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Medical Diagnostic Technologies, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Medical Diagnostic Technologies, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Medical Diagnostic Technologies, Inc. in the registry?

The most recently registered devices listed for Medical Diagnostic Technologies, Inc. include ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM, FACTOR XII DEFICIENT PLASMA, BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM and CYTOMEGALOVIRUS CONTROL SLIDES.

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