FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K163085 |
Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC |
Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack |
02/14/2017 |
K130470 |
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) |
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT |
04/02/2013 |
K172569 |
GenePOC Inc. |
GenePOC CDiff |
11/22/2017 |
K132235 |
Intelligent Medical Devices, Inc. |
IMDX C.DIFFICILE FOR ABBOTT M2000 |
10/11/2013 |
K171441 |
Luminex Corporation |
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit |
07/21/2017 |
K123197 |
NANOSPHERE, INC |
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) |
12/05/2012 |
K132726 |
PRIMERADX |
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM |
11/29/2013 |
K133936 |
QIAGEN, GMBH |
ARTUS C. DIFFICILE QS-RGQ MDX KIT |
04/04/2014 |
K123998 |
QUIDEL CORP. |
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY |
03/08/2013 |
K123355 |
QUIDEL CORPORATION |
AMPLIVUE C. DIFFICILE ASSAY |
12/13/2012 |
K170491 |
Quidel Corporation |
Solana C. difficile Assay |
05/11/2017 |
K171770 |
Roche Molecular Systems, Inc. |
cobas Cdiff Nucleic acid test for use on the cobas Liat System |
09/12/2017 |
K210385 |
Roche Molecular Systems, Inc. |
cobas Cdiff nucleic acid test for use on the cobas Liat System |
09/09/2021 |
K212427 |
Roche Molecular Systems, Inc. |
cobas Cdiff nucleic acid test for use on the cobas Liat System |
10/20/2021 |
K142422 |
ROCHE MOLECULAR SYSTEMS, INC. |
cobas Cdiff Test |
05/20/2015 |