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.
Catalogue
Search and filter all 57 devicesCoagulation Reference Plasma, Normal Ref K905203
Regimes: 510(k) Registry: 510(k)Venom Tiem Reagent Ref K955115
Regimes: 510(k) Registry: 510(k)Spectrolyse Antithrombin Iii (Anti-Xa) Ref K960871
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ctc Workstation, Model 2200 Ref K062229
Regimes: 510(k) Registry: 510(k)Abnormal Coagulation Control Plasma-2 (Accp-2) Ref K895261
Regimes: 510(k) Registry: 510(k)Factor Ix Deficient Plasma Ref K893524
Regimes: 510(k) Registry: 510(k)
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