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
Morphine Roche (R) Eia Test Ref K864168
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Bun Reagent Ref K896236
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Mfc Ref K885292
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Core Free T3 Eia Ref K942376
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen(R) Fp For Methamphetamine (500-1000) Ref K910756
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online Control Ref K931125
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Calibrator Serum Ref K942706
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Ammonia (Various) Ref K942048
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Standards For The Cobas Ise Module Ref K897071
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Cobas Micros Hematology Analyzer Ref K953448
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Control Serum P Ref K954656
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Reagent Ref K941573
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Unimate Fructosamine Reagent Ref K961674
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas(R)-Fp Reagents For T-Uptake/Calibrators Ref K926443
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICk-Nac Reagent Ref K834502
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online Tm For Thc Ref K904996
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Mira Ref K851172
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIon-Specific Electrode Option For Cobas Fara Ref K852473
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Core Fsh Eia Ref K930304
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abuscreen Online For Phencyclidine Ref K920935
Active Regimes: 510(k) Registry: 510(k) ClassClass:—Cobas Fara Centrifugal Analyzer Ref K893641
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cobas Ready Ast Reagent Ref K896238
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Cobas(R) Ammonia And Ethanol Calibrator Ref K914750
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Unimate Hdl Direct Reagen (With Pol Claim) Ref K973369
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbuscreen Online Controls Ref K945194
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRevised Labeling For Methaqualone Test Kit Ref K874272
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Standards For Glucose & Bun Ref K831030
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOntrak Testcup And Teststik Controls Ref K983387
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbuscreen(R) Ontrak(Tm) For Barbiturates Ref K881816
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abuscreen Radioimmunoassay For Amphetamine Ref K912755
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
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Ammonia/Ethanol/CO2 Calibrator Ref K952282
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Tri-Level Reference Controls Ref K894463
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Abuscreen Online Drug Free Urine Ref K953845
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Abuscreen Sample Oxidizing Reagent Ref K935042
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Core Ferritin Eia Ref K920829
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Calibrator Kit Ref K897097
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Fp Reagents For Quinidine Ref K850808
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Positive Reference Controls Ref K894464
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Reagent For C02 Ref K911838
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen(R) Ontrak(Tm) For Amphetamines Ref K881817
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRevised Labeling For Amphetamine Test Kit Ref K874273
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Triglyceride Reagent Ref K896231
Active Regimes: 510(k) Registry: 510(k) ClassClass:I
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