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Roche Diagnostics Corp.

Last updated May 23, 2026

What Roche Diagnostics Corp. makes

Roche Diagnostics Corp. manufactures in vitro diagnostic (IVD) devices for clinical chemistry, including analyte profile controls and calibrators, as well as standalone tests for substances like total bilirubin, magnesium, human chorionic gonadotropin, and parathyroid hormone. Their portfolio also includes rapid urine analyte tests, chemiluminescent immunoassays, and nephelometric/turbidimetric assays for proteins such as transferrin. Point-of-care (POC) and remote-access testing systems, as well as troponin, myoglobin, and thyroid-stimulating hormone assays, are also part of their offerings.

The company’s devices are regulated under FDA’s classification system, spanning Class I, Class II, Class III, and unclassified (U) categories. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. Roche Diagnostics Corp. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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EUDAMED SRN: —
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Catalogue (1711)

Page 33 of 35

Device	Model / Reference	Registries	Class	Status
Cobas Integra 400/800 Bilirubin Total	K081193	FDA 510(k)	Class II	Active
Elecsys Hcg And Beta Test System	K003178	FDA 510(k)	Class II	Active
Elecsys Anti-HCV II (08837031190)	K221693	FDA 510(k)	Class II	Active
Elecsys Ck-Mb Calcheck 5	K133284	FDA 510(k)	Class I	Active
Elecsys T3 Calcheck 5	K111552	FDA 510(k)	Class I	Active
CalSet IGF-1	K170938	FDA 510(k)	Class II	Active
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5	K162840	FDA 510(k)	Class II	Active
Tina-Quant Hba1c Gen. 2 Test System	DEN130002	FDA 510(k)	Class II	Active
Tina-Quant Apolipoprotein A-1 Ver.2	K013278	FDA 510(k)	Class I	Active
Factor Ii (prothrombin) G20210a Kit	K033612	FDA 510(k)	Class II	Active
Elecsys Testosterone II	K211685	FDA 510(k)	Class I	Active
Elecsys Estradiol Calset Ii	K992981	FDA 510(k)	Class II	Active
Coaguchek Xs Pro System	K093460	FDA 510(k)	Class II	Active
Cobas Integra Creatinine Plus Ver.2 Assay	K024098	FDA 510(k)	Class II	Active
Elecsys Hsv-2 Igg Immunoassay	K121895	FDA 510(k)	Class I	Active
Calibrator For Automated Systems (c.f.a.s.), Model 10759350 360	K062319	FDA 510(k)	Class II	Active
Roche Diagnostics Elecsys Prolactin Ii Calcheck	K053059	FDA 510(k)	Class I	Active
Amplicor Ct/Ng Test For Chlamydia Trachomatis; Roche Scripts For Ct/Ng Test Accessory	K070174	FDA 510(k)	Class I	Active
Elecsys Cortisol Test System	K070788	FDA 510(k)	Class II	Active
Modification To Roche Elecsys Folate Ii Immunoassay	K043318	FDA 510(k)	Class II	Active
Hdl Cholesterol Plus	K000568	FDA 510(k)	Class I	Active
Elecsys Digoxin Calcheck 5	K102044	FDA 510(k)	Class I	Active
Cobas Amplicor Ct/Ng Test For Chlamydia Trachomatis	K053287	FDA 510(k)	Class I	Active
Cobas 8000 Modular Series Analyzer	K100853	FDA 510(k)	Class II	Active
Roche Diagnostics Ck-Mb	K003158	FDA 510(k)	Class II	Active
Cobas Integra Amphetamines	K003865	FDA 510(k)	Class II	Active
Roche Fludi Methamphetamine	K093884	FDA 510(k)	Class II	Active
Elecsys Pth Test System	K070391	FDA 510(k)	Class II	Active
Elecsys Shbg Calcheck 5	K111349	FDA 510(k)	Class I	Active
Cobas Integra Bilirubin Special And Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, And 11822713 226	K063543	FDA 510(k)	Class II	Active
Tina-Quant Igg Gen.2	K050113	FDA 510(k)	Class II	Active
Cobas Integra Online Dat Ii Cocaine Ii	K023296	FDA 510(k)	Class II	Active
Beta-CrossLaps CalCheck 5	K170678	FDA 510(k)	Class I	Active
Accu-Chek Smart Pix	K062395	FDA 510(k)	Class II	Active
Accu-Chek Pocket Compass Diabetes Management Software	K050760	FDA 510(k)	Class II	Active
Amphetamines Ii Assay	K093664	FDA 510(k)	Class II	Active
Accu-Chek Aviva System	K043474	FDA 510(k)	Class II	Active
Cobas Integra Acetaminophen	K991598	FDA 510(k)	Class II	Active
Elecsys Anti-HAV IgM	K260048	FDA 510(k)	Class II	Active
Integra Reagent Cassette For Apolipoprotein B	K990595	FDA 510(k)	Class II	Active
Ontrak Testcup M2k And Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup M2k And Ontrak Teststick Negativ	K990377	FDA 510(k)	Class I	Active
Tina-Quant D-Dimer Test System	K011143	FDA 510(k)	Class II	Active
Elecsys Ca 125 Ii Calset	K003969	FDA 510(k)	Class II	Active
Accu-Chek Aviva Plus System	K133862	FDA 510(k)	Class II	Active
Elecsys Folate Ii Calset Ii	K042490	FDA 510(k)	Class II	Active
Modification To Accu-Chek Go System	K051592	FDA 510(k)	Class II	Active
Modification To Roche Elecsys Folate Ii Calcheck Ii	K043320	FDA 510(k)	Class I	Active
Preciset Dat Plus I Calibrators	K031775	FDA 510(k)	Class II	Active
C.f.a.s. Proteins, C.f.a.s. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein	K133330	FDA 510(k)	Class II	Active
Omni Modular, Omni C And Omni S Analyzer (ph Electrode)	K050423	FDA 510(k)	Class II	Active

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