Medical Analysis Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 107
What Medical Analysis Systems, Inc. makes
Medical Analysis Systems, Inc. manufactures liquid reagent sets, assay controls, and therapeutic drug monitoring controls for clinical laboratory use. Products include urinalysis controls, enzymatic and immunologic reagents for lipid panels, fructosamine, apolipoprotein A-1, and cardiac biomarkers like proBNP and troponin T. The company also supplies multi-analyte therapeutic drug controls and enzyme-based reagent kits for serum assays, such as SGOT.
The portfolio consists of Class I and Class II devices, with regulatory submissions recorded in the FDA’s 510(k) database. These products are intended for in vitro diagnostic use and comply with U.S. regulatory requirements. The company is based in the United States.
Catalogue
Search and filter all 107 devicesChem Trak Liquid Bilirubin Control Ref K833097
Regimes: 510(k) Registry: 510(k)Cpk Reagent Set, Nad Reduction Ref K781719
Regimes: 510(k) Registry: 510(k)Lipase Sr Liquid Stable Reagent Set Ref K885078
Regimes: 510(k) Registry: 510(k)Immunology Control Ref K960824
Regimes: 510(k) Registry: 510(k)Hdl-Cholesterol Precipitating Reagent Ref K883543
Regimes: 510(k) Registry: 510(k)Cpk Reagent Set Ref K780070
Regimes: 510(k) Registry: 510(k)Mas Liquid Urinalysis Control Ref K935062
Regimes: 510(k) Registry: 510(k)
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