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
Abuscreen Online Tm For Opiates Ref K904997
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Modification To Abuscreen Online Barbiturates Ref K983698
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen(R) Ontrak(Tm) For Thc Ref K881814
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Bun Ref K954000
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas-Fibro Ref K842717
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abuscreen Online For Amphetamines With Periodate - Olympus AU800/1000 Instrument Application Ref K972891
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Glucose Ref K953847
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Enterotube Ii Ref K922588
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRevised Labeling For Pcp Test Kit Ref K874267
Active Regimes: 510(k) Registry: 510(k) ClassClass:—- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Reagent For Ast Ref K843109
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen (R) Eia Cannabinoids Ref K870377
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Uric Acid Reagent Ref K896227
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Cobas Futura Glucose Ref K922811
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Magnesium Ref K901758
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbuscreen Fp For Cannabinoids (50-100) Ref K910589
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Immunoassay For Theophylline & Cal Ref K843826
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Standards For Chloride & CO2 Ref K850396
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Roche Chloride Electrode Ref K890528
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Reagent For Ggt Ref K924246
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbuscreen Fp Buffer Reagent Ref K890883
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas(R) Core T3 Eia Ref K932608
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOntrak Testcup-Er Ref K983388
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online Low-Cutoff Controls Ref K932549
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIsomune-Amylase And Isomune-Amylase Control Ref K873250
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Cobas Ready Amylase Reagent Ref K903309
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abuscreen Online Tm For Cocaine Metabolite Ref K904995
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Ref K896007
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Ready Total Bilirubin Reagent Ref K896232
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRevised Labeling For Cocaine/Cocaine Meta. Test Ref K874271
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Ready Profile 2 Reagent Strip Ref K896225
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobas Ready Alt Reagent Ref K896237
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbuscreen Online Propoxphene Ref K945195
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Cobas Ibtegra Reagent Cassettes Ref K964457
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cobas Calibrator Serum Ref K850859
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Ethanol Ref K913125
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Ldh Ref K900121
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Alt Ref K843111
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Reagent For Chloride, For The Cobas Ref K850334
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Ontrak Pos. Ref. Control For Cocaine Ref K893859
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Ontrak Testcup 5 (Modification) Ref K964355
Active Regimes: 510(k) Registry: 510(k) ClassClass:—Roche Standards For Uric Acid Ref K843112
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Cobas Ready Alkaline Phosphatase Reagent Ref K902560
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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