# Roche Diagnostics Corp.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Roche Diagnostics Corp. is a medical device manufacturer, with 469 devices listed in FDA 510(k), FDA PMA and FDA GUDID (FDA Class II, Class I, Unclassified and Class III) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/roche-diagnostics-corp>
- Also registered as: Roche Diagnostics; Roche Diagnostics Corporation; Roche Diagnostics, Inc.
- Country: United States (FDA applicant, unverified)
- Role: Manufacturer

## Figures

- Devices: 469
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA 510(k) 454, FDA PMA 15, FDA GUDID 3
- Device classes: FDA Class II 359, FDA Class I 104, FDA Unclassified 5, FDA Class III 1

## Devices

The first 50 of 469, in the order of the canonical page, which lists them all.

- [Coaguchek Xs System](https://devicerts.com/devices/coaguchek-xs-system-gjs) · ref K062925 · Class II · 510(k) · status: Active · decision 2007-01-29
- [cobas pulse blood glucose monitoring system](https://devicerts.com/devices/cobas-pulse-blood-glucose-monitoring-system-pzi-k252323) · ref K252323 · Class II · 510(k) · status: Active · decision 2026-06-12
- [Elecsys EBV IgM](https://devicerts.com/devices/elecsys-ebv-igm-ljn) · ref K260233 · Class I · 510(k) · status: Active · decision 2026-10-02
- [Elecsys EBV VCA IgG](https://devicerts.com/devices/elecsys-ebv-vca-igg-lse) · ref K260232 · Class I · 510(k) · status: Active · decision 2026-10-02
- [Elecsys EBV EBNA IgG](https://devicerts.com/devices/elecsys-ebv-ebna-igg-lse) · ref K260221 · Class I · 510(k) · status: Active · decision 2026-10-02
- [Elecsys Phospho-Tau (217P) Plasma](https://devicerts.com/devices/elecsys-phospho-tau-217p-plasma-set) · ref K261686 · Class II · 510(k) · status: Active · decision 2026-08-19
- [Modification To:cobas Integra Hdl-Cholesterol Plus 2ND Generation](https://devicerts.com/devices/modification-to-cobas-integra-hdl-cholesterol-plus-2nd-gener-lbs) · ref K012286 · Class I · 510(k) · status: Active · decision 2001-08-08
- [Preciset Dat Amphetamine Calibrators; Cfas Dat Qualitative Amphetamine Calibrators](https://devicerts.com/devices/preciset-dat-amphetamine-calibrators-cfas-dat-qualitative-am-dlj) · ref K033165 · Class II · 510(k) · status: Active · decision 2003-10-14
- [Elecsys Probnp Ii, Precicontrol Cardiac Ii, Probnp Ii Calset](https://devicerts.com/devices/elecsys-probnp-ii-precicontrol-cardiac-ii-probnp-ii-calset-nbc) · ref K072437 · Class II · 510(k) · status: Active · decision 2008-02-05
- [Roche Elecsys Anti-Tg](https://devicerts.com/devices/roche-elecsys-anti-tg-jzo) · ref K053426 · Class II · 510(k) · status: Active · decision 2006-02-07
- [Elecsys Anti-Tpo Calcheck](https://devicerts.com/devices/elecsys-anti-tpo-calcheck-jjx) · ref K001014 · Class I · 510(k) · status: Active · decision 2000-06-01
- [Elecsys Rubella Igg Calcheck](https://devicerts.com/devices/elecsys-rubella-igg-calcheck-jjx) · ref K090311 · Class I · 510(k) · status: Active · decision 2009-05-05
- [Roche Diagnostics Cobas Integra Albumin Gen. 2](https://devicerts.com/devices/roche-diagnostics-cobas-integra-albumin-gen-2-cix) · ref K033009 · Class II · 510(k) · status: Active · decision 2003-10-16
- [Elecsys HSV-2 IgG (08948887160)](https://devicerts.com/devices/elecsys-hsv-2-igg-08948887160-myf) · ref K220924 · Class II · 510(k) · status: Active · decision 2022-10-12
- [Elecsys Syphilis](https://devicerts.com/devices/elecsys-syphilis-lip-k160910) · ref K160910 · Class II · 510(k) · status: Active · decision 2016-07-28
- [Roche Elecsys Troponin T Stat (Short Turnaround Time)](https://devicerts.com/devices/roche-elecsys-troponin-t-stat-short-turnaround-time-mmi) · ref K051752 · Class II · 510(k) · status: Active · decision 2005-07-11
- [Elecsys Ige Calcheck 5](https://devicerts.com/devices/elecsys-ige-calcheck-5-jjx) · ref K102269 · Class I · 510(k) · status: Active · decision 2010-10-07
- [Accu-Chek Aviva Test Strips](https://devicerts.com/devices/accu-chek-aviva-test-strips-nbw) · ref K060620 · Class II · 510(k) · status: Active · decision 2006-08-11
- [Modification To Reflotron Amylase, Cat. 1200658](https://devicerts.com/devices/modification-to-reflotron-amylase-cat-1200658-jfj) · ref K011145 · Class II · 510(k) · status: Active · decision 2001-06-25
- [Elecsys Hcg Stat Claset Ii](https://devicerts.com/devices/elecsys-hcg-stat-claset-ii-jis) · ref K003941 · Class II · 510(k) · status: Active · decision 2001-01-25
- [Modification To Elecsys Fsh Ii Calset](https://devicerts.com/devices/modification-to-elecsys-fsh-ii-calset-jit) · ref K012399 · Class II · 510(k) · status: Active · decision 2001-08-24
- [Chemstrip 5 Ob, Chemstrip 7 And Chemstrip 10 Md Test Strips](https://devicerts.com/devices/chemstrip-5-ob-chemstrip-7-and-chemstrip-10-md-test-strips-jil) · ref K032437 · Class II · 510(k) · status: Active · decision 2003-10-08
- [Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323](https://devicerts.com/devices/tina-quant-soluble-transferrin-receptor-test-system-hitachi-ddg) · ref K003064 · Class II · 510(k) · status: Active · decision 2001-05-01
- [Elecsys Anti-TSHR](https://devicerts.com/devices/elecsys-anti-tshr-jzo) · ref K193313 · Class II · 510(k) · status: Active · decision 2020-02-27 · open recall
- [Ise Indirect Na, K, C1 For Gen 2](https://devicerts.com/devices/ise-indirect-na-k-c1-for-gen-2-jgs) · ref K140373 · Class II · 510(k) · status: Active · decision 2014-05-22
- [Ceruloplasmin, Model 2055953](https://devicerts.com/devices/ceruloplasmin-model-2055953-chn) · ref K062114 · Class II · 510(k) · status: Active · decision 2007-01-31
- [Tina-Quant Hemoglobin A1C GEN.2 Test](https://devicerts.com/devices/tina-quant-hemoglobin-a1c-gen-2-test-lcp) · ref K052464 · Class II · 510(k) · status: Active · decision 2005-09-30
- [Elecsys Anti-Tpo Calset](https://devicerts.com/devices/elecsys-anti-tpo-calset-jix) · ref K103171 · Class II · 510(k) · status: Active · decision 2011-02-11
- [Online Phenobarbital, Model 03016757190 & 03510620](https://devicerts.com/devices/online-phenobarbital-model-03016757190-and-03510620-dlz) · ref K071644 · Class II · 510(k) · status: Active · decision 2007-09-12
- [Elecsys sFlt-1 and Elecsys PlGF](https://devicerts.com/devices/elecsys-sflt-1-and-elecsys-plgf-qwh) · ref K241453 · Class II · 510(k) · status: Active · decision 2025-02-07
- [Coaguchek Xs Pt Controls](https://devicerts.com/devices/coaguchek-xs-pt-controls-ggn) · ref K063823 · Class II · 510(k) · status: Active · decision 2007-01-29
- [Elecsys CYFRA 21-1 CalCheck 5](https://devicerts.com/devices/elecsys-cyfra-21-1-calcheck-5-jjx) · ref K162173 · Class I · 510(k) · status: Active · decision 2017-01-12
- [Oral Fluid Phencyclidine](https://devicerts.com/devices/oral-fluid-phencyclidine-lcm) · ref K093989 · Unclassified · 510(k) · status: Active · decision 2011-01-25
- [Elecsys Toxo Igg Calcheck](https://devicerts.com/devices/elecsys-toxo-igg-calcheck-jjx) · ref K083655 · Class I · 510(k) · status: Active · decision 2009-02-12
- [Calcium Gen. 2](https://devicerts.com/devices/calcium-gen-2-chw) · ref K113521 · Class II · 510(k) · status: Active · decision 2012-05-08
- [Act Test Catridges For Coaguchek Pro System, Act Controls For Coaguchek Pro System](https://devicerts.com/devices/act-test-catridges-for-coaguchek-pro-system-act-controls-for-jbp) · ref K992851 · Class II · 510(k) · status: Active · decision 2000-01-14
- [Elecsys Testosterone Ii Immunoassay](https://devicerts.com/devices/elecsys-testosterone-ii-immunoassay-cdz) · ref K093421 · Class I · 510(k) · status: Active · decision 2010-04-23
- [Cobas Integra Carbon Dioxide Assay](https://devicerts.com/devices/cobas-integra-carbon-dioxide-assay-khs) · ref K031879 · Class II · 510(k) · status: Active · decision 2003-07-17
- [Elecsys AMH](https://devicerts.com/devices/elecsys-amh-pqo) · ref K203757 · Class II · 510(k) · status: Active · decision 2022-06-10
- [Elecsys Hcg Stat Calcheck 5](https://devicerts.com/devices/elecsys-hcg-stat-calcheck-5-jjx) · ref K093700 · Class I · 510(k) · status: Active · decision 2010-03-04
- [Abuscreen Online Opiates 300 / 2000](https://devicerts.com/devices/abuscreen-online-opiates-300-2000-djg) · ref K013482 · Class II · 510(k) · status: Active · decision 2001-12-21
- [Tina-Quant Apolipoprotein B VER.2](https://devicerts.com/devices/tina-quant-apolipoprotein-b-ver-2-dfc-k013206) · ref K013206 · Class II · 510(k), GUDID · status: Active · decision 2001-11-16
- [Elecsys FT4 III](https://devicerts.com/devices/elecsys-ft4-iii-cec) · ref K181233 · Class II · 510(k) · status: Active · decision 2018-09-18
- [Ontrak Testcup 501, Model 3016633](https://devicerts.com/devices/ontrak-testcup-501-model-3016633-dkz) · ref K001421 · Class II · 510(k) · status: Active · decision 2000-07-12
- [Ontrak Testcup Pro-5, Model 1986678](https://devicerts.com/devices/ontrak-testcup-pro-5-model-1986678-djc) · ref K001356 · Class II · 510(k) · status: Active · decision 2000-07-10
- [Tina-Quant HBA1C GEN.2](https://devicerts.com/devices/tina-quant-hba1c-gen-2-lcp) · ref K110313 · Class II · 510(k) · status: Active · decision 2011-12-23
- [Roche Diagnostics Calibrator For Automated Systems, Roche Diagnostics Calibrator Calibrator For Automated System](https://devicerts.com/devices/roche-diagnostics-calibrator-for-automated-systems-roche-dia-jix) · ref K101456 · Class II · 510(k) · status: Active · decision 2010-09-08
- [Ontrak Testcup-Er M2K](https://devicerts.com/devices/ontrak-testcup-er-m2k-dkz) · ref K990418 · Class II · 510(k) · status: Active · decision 1999-04-13
- [Elecsys C-Peptide Calcheck 5](https://devicerts.com/devices/elecsys-c-peptide-calcheck-5-jjx) · ref K100810 · Class I · 510(k) · status: Active · decision 2010-04-26
- [Elecsys Insulin Calset](https://devicerts.com/devices/elecsys-insulin-calset-jis) · ref K001906 · Class II · 510(k) · status: Active · decision 2000-07-13

## Source and citation

- Cite as: Roche Diagnostics Corp. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/roche-diagnostics-corp (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA PMA](https://open.fda.gov/apis/device/pma/), [FDA GUDID](https://accessgudid.nlm.nih.gov/)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/roche-diagnostics-corp.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/roche-diagnostics-corp
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.