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
Stratus Gentamicin Fluorometric Enzym Ref K832445
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIProteolytic Enzyme Control Ref K803110
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITek-Pro Tek-Tator V Rotator & Humidify Ref K820043
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAqueous Blood Gas Control Level I, Ii & Ref K832003
Active Regimes: 510(k) Registry: 510(k) ClassClass:IS/P Vortex Mixer Jr. Ref K813149
Active Regimes: 510(k) Registry: 510(k) ClassClass:IHemotology Calibrator Ref K813530
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBovine Chemistry Control I.x And Ii.x Ref K860355
Active Regimes: 510(k) Registry: 510(k) ClassClass:IVonwillebrand Factor Antigen Semi-Quant Ref K842617
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStratus Thyroid Uptake Fluorometric Ref K834209
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Blood Gas Ampul Injector Ref K852285
Active Regimes: 510(k) Registry: 510(k) ClassClass:IActin Fsl Activated Ptt Reagent Ref K863594
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Hematology Calibrator Ref K831140
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAlpha-Antiplasm Assay Ref K802840
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:—
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Paramax Alkaline Phosphatase Reagent- Ref K831480
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStratus Theophylline Assay Ref K832965
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILectin-A Ref K820368
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILectin H Ref K813413
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStratus Tdm Control, Levels I, Ii, Iii Ref K820296
Active Regimes: 510(k) Registry: 510(k) ClassClass:IParamax Urine/Csf Calibrator Ref K872789
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIS/P Sure-Cap Ref K812921
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Paramax Comprehensive Calibrator Ref K855199
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIS/P Capillary Tubes, Heparinized (3A) Ref K812970
Active Regimes: 510(k) Registry: 510(k) ClassClass:IStratus Phenobarbital Fluorometric Enz Ref K830701
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Thromboplastin - Fs Ref K833272
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStratus Ige Fluorometric Enzyme Immunoassay Ref K871972
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINeonatal Bilirubin Reagent Ref K840779
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIParamax Calcium Reagent-Glutamy-Trans Ref K832708
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIS/P Serum Dropper Pipets Ref K812892
Active Regimes: 510(k) Registry: 510(k) ClassClass:IS/P Sure-Cap N Ref K812923
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Smi Multipettor(Tm) Ref K863887
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDisposable Dispensing-Spread Pipets Ref K822292
Active Regimes: 510(k) Registry: 510(k) ClassClass:IParamax Bilirubin Calibrators Ref K833005
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIParamax Alcohol Reagent Ref K840769
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIData-Fi Dimertest Latex Assay Ref K872195
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Disp. Dispensing-Spreading Pipets Ref K822078
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICh-60 Plus /Abnormal Low/Blood Platelet Ref K802143
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIParamax Alanine Aminotransferase Ref K840705
Active Regimes: 510(k) Registry: 510(k) ClassClass:IHematology Control Ref K812280
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Rh Control Reagent Ref K810599
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICoagulation Factor V Deficient Substr Ref K841364
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Hematology Calibrator Plus Ref K840010
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDade Factor Assay Reference Plasma Ref K820085
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIThromboplastin.r Ref K864274
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIQap Microcomputer System Ref K823110
Active Regimes: 510(k) Registry: 510(k) ClassClass:IParamax Chloride Reagent Ref K841047
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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