American Dade
Country not established
- Devices
- 149
What American Dade makes
American Dade manufactures diagnostic reagents for clinical chemistry and immunoassay testing, including creatine kinase MB, lactate, uric acid, cortisol, and thyroid uptake assays. Their portfolio also covers enzyme-based assays like phenytoin and N-acetyl-β-glucosaminidase (NAPA), as well as reagents for measuring carbon dioxide and iron levels. Bovine chemistry controls are provided for quality assurance in laboratory settings.
The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) device categories, with many authorised via the 510(k) pathway. These reagents are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Paramax Phosphorus Reagent Ref K833002
Active Regimes: 510(k) Registry: 510(k) ClassClass:IStratus Ferritin Fluorometric Enzyme Immunoassay Ref K862818
Active Regimes: 510(k) Registry: 510(k) ClassClass:IStratus Hcg Fluorometric Enzyme Immunoassay Ref K850570
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Lithium Heparinized Blood Collect-Tube Ref K831242
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISeries I/S Infections Ref K844289
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStratus Tsh Fluorometric Enzyme Immunoassay Ref K862428
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIThromboplastin.fs Ref K864272
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAlcohol & Ammonia Calibrator I Ref K840771
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIClotting Time Reagent Ref K820084
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIS/P Vortex Mixer Ref K813148
Active Regimes: 510(k) Registry: 510(k) ClassClass:IBleeding Time Device Disposable Ref K830645
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Stratus Primidone Florometric Enzy Ref K842196
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIParamax Amaline Reagent Ref K831536
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIParamax & Glutamytransferase Reagent Ref K833001
Active Regimes: 510(k) Registry: 510(k) ClassClass:IParamax Urea Nitrogen Reagent Ref K840785
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIImmunoadsorbed Factor X Deficient Plasma (Human) Ref K870353
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIParamax Salicylate Reagent Ref K833003
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Moni-Trol Chemistry Control/Calibrator Ref K871977
Active Regimes: 510(k) Registry: 510(k) ClassClass:IParamax Lipase Reagent Ref K862440
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICoagulation Factor Ix Deficient Substrate Plasma Ref K853461
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIParamax Total Protein Reagent Tp Ref K845052
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICarbon Dioxide Calibrator Ii Ref K840775
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIImmu-Trace Digoxin (125I) Radioimmun. Ref K803045
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIFibrinogen Control Plasma Ref K811069
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITriglycerides Reagent Ref K840780
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAlbumin Reagent Ref K840782
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIParaamax Chloride Determination By Ise Ref K854651
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDade Esr Kit Ref K823368
Active Regimes: 510(k) Registry: 510(k) ClassClass:IParamax Total Bilirubin Reagent Ref K833004
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Chill Tray Ref K822132
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Moni-Tro Es Chemistry Control Level Ix Ref K822850
Active Regimes: 510(k) Registry: 510(k) ClassClass:IStratus Total Thyroxine Fluorometric Ref K834210
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Stratus(R) Ck-Mb Fluorometric Enzyme Immunoassay Ref K873171
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICarbon Dioxide Calibrator I Ref K840774
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPrototro/Proteolytic Enzyme Control Ref K831297
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICi-Trol Heparin Controls, Low/High Ref K812424
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICh-60 Plus Whole Blood Platelet Control Ref K802141
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Rpr Card Test Ref K811152
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStrat Thyroid Uptake Fluromet Enzyme Immunoassay Ref K860422
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Immu-Trace Tri-Rac R Tri-Level Controls Ref K823352
Active Regimes: 510(k) Registry: 510(k) ClassClass:IProtopath Factor Ix Assay Ref K834050
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIS/P Capillary Tubes, Heparinized (2A) Ref K812969
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDirect Bilirubin Reagent Ref K840777
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStratus(R) Hfsh Fluorometric Enzyme Immunoassay Ref K873051
Active Regimes: 510(k) Registry: 510(k) ClassClass:I
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