Roche Diagnostic Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 296
What Roche Diagnostic Systems, Inc. makes
Roche Diagnostic Systems, Inc. manufactures diagnostic reagents and systems for laboratory testing, including immunoassay systems like the COBAS Core Immunochemistry System, as well as specific reagents for measuring substances such as cocaine metabolites, apolipoprotein B, bilirubin, and hemoglobin A1c. The company also produces drug testing kits for substances like amphetamines, methadone, and morphine, alongside calibrators and controls for these assays.
These devices are classified under FDA categories Class I, Class II, and Unclassified (U), with regulatory submissions recorded in the FDA’s 510(k) database. 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:II
Roche Cobas Ready Renal Profile Reagent Strip Ref K904049
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Separating Reagent For Hdl Cholesterol Ref K900120
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Reagent For Chloride Ref K884013
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen(R) Online(Tm) Thc Calibrators Ref K912048
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Abuscreen Tri-Level Reference Controls Ref K932753
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online Cocaine Metabolite Calibrators Ref K910086
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas-Fp Tdm Calibration Verification Test Set Ref K962165
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Reagent For Creatinine Ref K941837
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Apolipoprotein Standard Ref K910553
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Reagents For Gentamicin & Calibrat Ref K843827
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas(R) Core FT4 Eia Ref K932607
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Fara Ii Centrifugal Analyzer Ref K893854
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRotag Fructosamine (Glycated Protein) Assay Ref K900718
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Oxi/Ferm Ii Ref K923313
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Ready Total Protein Reagent Ref K896230
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Fluorescence Polarization Module Ref K843914
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abuscreen(R) Online(Tm) For Barbiturates Ref K914468
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas(R) Core Ige Total Eia Ref K930890
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online For Amphetamines Ref K912758
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Abuscreen Online For Methaqualone Ref K945187
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Fp Benzodiazephine Reagent Ref K891697
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Core Tsh Eia Ref K930776
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Fp For Morphine Ref K890888
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Ammonia Ref K913124
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Isomune- Ck Ref K903025
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Radioimmunoassay For Cannabiniods Ref K912757
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Alpha Ref K910222
Active Regimes: 510(k) Registry: 510(k) ClassClass:IFructosamine Test (Roche) Ref K854010
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Fp For Methamphetamine Ref K900143
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Fp Reagents For Carbamazepine Ref K850807
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Fp Reagents For Phenytoin & Calibr Ref K843824
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cobas Ready Cardio Profile Reagent Strip Ref K896228
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online For Thc (50 And 100) Ref K912574
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRevised Labeling For Amphetamine Test Kit Ref K874274
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRocho Isomune - Ld Ref K894081
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cobas-Fp Reagents And Calibrators Ref K941712
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbiscreen Online For Cannabinoids - Es 50/100 Ref K961620
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Radioimmunoassay For Methamphetamine Ref K912754
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:II
Roche Cobas Ready Creatinine Reagent Ref K902561
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online For Cannabinoids (100 Test Kit) Ref K981584
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online(R) Calibrators Ref K931124
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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