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:I
Cobas Fp Reagents For Theophylline & Calibrators Ref K871484
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Ontrak For Cocaine (200NG/Ml) Ref K905730
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRevised Labeling For Benzodiazepine Test Kit Ref K874265
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Fp For Cannabinoids (15-50) Ref K910592
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Reagent For Triglycerides Ref K893973
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Cobas Mira Plus Ref K920402
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Cobas Ready Hdl Cholesterol Reagent Ref K902935
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbuscreen Online Low-Cutoff Calibrators Ref K932548
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Ontrak For Phencyclidine (Pcp) Ref K895906
Active Regimes: 510(k) Registry: 510(k) ClassClass:—- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abuscreen(R) Online(Tm) Calibrators Ref K913335
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Ontrak For Benzodiazepine Ref K910590
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen(R) Online(Tm) Controls Ref K913336
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Cobas-Fp Reagents For Tobramycin Ref K964670
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Abuscreen Ontrak For Thc Ref K904856
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Fp For Phencyclidine Ref K890882
Active Regimes: 510(k) Registry: 510(k) ClassClass:—Abuscreen Fp For Cocaine Metabolite Ref K890885
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOntraj Testcup Collection/Urinalysis Panel Ref K954799
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRevised Labeling For Cannabinoids Test Kit Ref K874269
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cobas-Fp Quinidine Reagents And Calibrators Ref K941440
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Uric Acid--Modification Ref K922762
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Cobas-Fp Reagents For Vancomycin Ref K953528
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen(R) Online Controls Ref K910689
Active Regimes: 510(k) Registry: 510(k) ClassClass:IOntrak Testtcup Collection/Urinalysis Panel Ref K964422
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Cobas Argos 5 Diff Ref K912615
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICobas Core Prolactin Eia Ref K930305
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cobas Integra Hdl-Cholesterol Direct Ref K973284
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche-Tdm Onlein(Tm) Controls Ref K946119
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Cardiotrol-Ck Ref K930889
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRoche Crp T Control N Ref K982087
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Standards For Cholesterol Ref K843110
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Ontrak Positive Control Ref K943999
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines With B-Glucuronidase (Bnzgl) Ref K974695
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Radioimmunoassay For Benzodiazepines Ref K870994
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIsoscreen-Ck Confirmatory Kit Ref K895870
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen(R) Online(Tm) For Benzodiazepines Ref K914509
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbuscreen Online Lsd Reagent (90 Ml Test Kit) Ref K961436
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRoche Reagent For Total Bilirubin Ref K910591
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Roche Tdm Calibration Verification Test Set Ref K942114
Active Regimes: 510(k) Registry: 510(k) ClassClass:I
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