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 Integra Reagent Cassettes Ref K954992
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Cobas Ready Ggt Reagent Ref K903304
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Eia(Tm) Photometer Ref K881877
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas(R)-Fp Reagent For Procainamide/Calibrator Ref K942847
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Glucose Reagent Ref K895526
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagents Reagent For Uric Acid Ref K844986
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRotag Controls Ref K900719
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Ready Ldh Reagent Ref K896241
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Abuscreen Online Cannabinoids Calibrators Ref K910085
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Abuscreen Online For Opiates 1000 Test Kit-2000 Ng/Ml Cutoff Olympus AU800 Instrument Application Ref K951319
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Ck Reagent Ref K896240
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Reagent For Apolipoprotein A-1 Ref K910551
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Cobas Reagent For Lidocaine & Calibrators Ref K853010
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online Controls Ref K953739
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Core Immunochemistry System Ref K921180
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Reagent For Uric Acid Ref K894101
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
Cobas-Fp Reagent For Valproic Acid & Calibrators Ref K891581
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen(R) Ontrak(Tm) For Cocaine Ref K881815
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas (R) Core T4 Eia Ref K932605
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Ontrak For Methamphetamine Ref K910658
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Hemoglobin A1C Control N And Control P Ref K972721
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Integra Reagent Cassettes Ref K982382
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Roche Reagent For Alt Ref K924245
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Core Lh Eia Ref K930306
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRevised Labeling For Barbiturate Test Kit Ref K874266
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Profile 1 Reagent Strip Ref K896229
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Fp Reagents For Napa And Napa Calibrators Ref K852319
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Calcium Reagent Ref K896224
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas-Fp Reagents For Vancomycin Ref K901759
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagents Reagent For CO2 Ref K844987
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche(R) Cardioscreen-Ck Ref K891462
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cobas Fp Tdm Controls Ref K843913
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICocaine Metabolite Roche(R) Eia Ref K863843
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Fp For Amphetamine Ref K890886
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Fp For Barbiturates Ref K890884
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online Benz 200 Calibrators Ref K983555
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cobas Ready Liver Profile Reagent Strip Ref K896233
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Cholesterol Reagent Ref K896239
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Reagent For Inorganic Phosphorus Ref K883962
Active Regimes: 510(k) Registry: 510(k) ClassClass:I
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