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OZN — C. Difficile Toxin Gene Amplification Assay Class II

FDA Device Classification

Classification Details

Product Code
OZN
Device Class
Class II
Regulation Number
866.3130
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243730cepheid®Xpert C. difficile/EpiFebruary 28, 2025
K232092vela operations usaGreat Basin Toxigenic C. difficile Direct Test (CDF2)November 14, 2023
K212427roche molecular systemscobas Cdiff nucleic acid test for use on the cobas Liat SystemOctober 20, 2021
K210385roche molecular systemscobas Cdiff nucleic acid test for use on the cobas Liat SystemSeptember 9, 2021
K172569genepocGenePOC CDiffNovember 22, 2017
K171770roche molecular systemscobas Cdiff Nucleic acid test for use on the cobas Liat SystemSeptember 12, 2017
K171441luminex corporationARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File KiJuly 21, 2017
K170491quidel corporationSolana C. difficile AssayMay 11, 2017
K163085focus diagnostics, inc.:dba diasorin molecularSimplexa C. difficile Direct; Simplexa C. difficile Positive Control PackFebruary 14, 2017
K142422roche molecular systemscobas Cdiff TestMay 20, 2015
K133936qiagenARTUS C. DIFFICILE QS-RGQ MDX KITApril 4, 2014
K132726primeradxICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEMNovember 29, 2013
K132235intelligent medical devicesIMDX C.DIFFICILE FOR ABBOTT M2000October 11, 2013
K130470geneohm sciences canada, inc. (bd diagnostics)BD MAX CDIFF ASSAY, BD MAX INSTRUMENTApril 2, 2013
K123998quidelQUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAYMarch 8, 2013
K123355quidel corporationAMPLIVUE C. DIFFICILE ASSAYDecember 13, 2012
K123197nanosphereVERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)December 5, 2012