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 devicesShowing 1-50 of 107
Frequently asked questions
How many devices does Medical Analysis Systems, Inc. have in the registry?
The registry currently lists 107 devices for Medical Analysis Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medical Analysis Systems, Inc.'s devices?
Among its 50 most recently registered devices, Medical Analysis Systems, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Medical Analysis Systems, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Medical Analysis Systems, 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 Analysis Systems, Inc. in the registry?
The most recently registered devices listed for Medical Analysis Systems, Inc. include DADE ASSAYED URINALYSIS CONTROL, AMYLASE SR LIQUID STABLE REAGENT SET, MAS LIPID LEVEL 1 AND 2 and TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG.