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.
AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Uric-Acid Ref K813511
Active Regimes: 510(k) Registry: 510(k) ClassClass:IGama-Gpt Reagent Set Ref K780071
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Reagent Set, Total Protein Ref K781722
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Tdm Plus Xl Enhanced Liq Drug Control I, Ii, Iii Ref K904141
Active Regimes: 510(k) Registry: 510(k) ClassClass:IReagent Set, Cholesterol Ref K781721
Active Regimes: 510(k) Registry: 510(k) ClassClass:ILipid Control Ref K960862
Active Regimes: 510(k) Registry: 510(k) ClassClass:IMas, Dade And Liquid Assayed Diabetes Control Ref K042717
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Doa Liquid Drugs Of Abuse Controls Ref K934498
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAcid Phosphatase Reagent Ref K892393
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Csf Liquid Cerebrospinal Fluid Control Ref K952877
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Calcium Liquid Stable Reagent Set Ref K855041
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIUrichemtrak Liquid Assayed Urine Control Ref K031441
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Mas Liquid Urinalysis Control Ref K954323
Active Regimes: 510(k) Registry: 510(k) ClassClass:IGlucose Hexokinase, Auto K Ref K781723
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPar(Tm) Brand Drug Of Abuse Controls Ref K880152
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Cardioisozyme, Ck/Ld Isoenzyme Control Ref K970856
Active Regimes: 510(k) Registry: 510(k) ClassClass:INad Reduction Method, Lactate Pyrivate Ref K781724
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIHbdh Reagent Set Ref K780073
Active Regimes: 510(k) Registry: 510(k) ClassClass:ITotal Protein Liquid Stable Reagent Set Ref K851877
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Ldh-L Reagent Set Ref K780074
Active Regimes: 510(k) Registry: 510(k) ClassClass:—Moni-Trol-L And Moni-Trol-Xl Ref K920291
Active Regimes: 510(k) Registry: 510(k) ClassClass:IMagnesium Reagent Ref K891355
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Amylase Sr Liquid Stable Reagent Set Ref K885176
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Hbdh Enzyme Kinetic Reagent Set Ref K781720
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDoa Liquid Multi-Analyte Drugs Of Abuse Controls Ref K904905
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Moni-Trol Xl And L Unassayed Liquid Chemistry Ref K903190
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
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