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LLH — Reagents, Clostridium Difficile Toxin Class I

FDA Device Classification

Classification Details

Product Code
LLH
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K193490first light diagnosticsSensiTox C. difficile Toxin TestJuly 8, 2021
K102242genzyme corporationOSOM C. DIFFICILE TOXIN A/B TESTDecember 21, 2010
K091109cepheidXPERT C. DIFFICILEJuly 9, 2009
K090239prodessePROGASTRO CD ASSAYApril 16, 2009
K082499techlabC. DIFF QUIK CHEK COMPLETEMarch 26, 2009
K081920bd diagnostics (geneohm sciences, inc.)BD GENEOHM CDIFF ASSAYDecember 19, 2008
K080931biomerieuxVIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYJune 11, 2008
K072138biomerieuxVIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118December 21, 2007
K050891techlabTOX A/B QUICK CHEKJuly 25, 2005
K041951remelXPECT CLOSTRIDIUM DIFFICILE TOXIN A/BNovember 15, 2004
K041003meridian bioscienceIMMUNOCARD TOXINS A & B, MODEL 712050August 20, 2004
K032897ivd researchC. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFMay 27, 2004
K033479remelPROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYFebruary 26, 2004
K030992techlabC. DIFF CHEK - 60July 11, 2003
K030991techlabC. DIFF CHEK - 30July 11, 2003
K030404techlabC. DIFFICILE TOX A/B IIApril 24, 2003
K003306techlabC. DIFFICILE TOX A/B IINovember 22, 2000
K993914meridian diagnosticsPREMIER TOXINS A&B, MODEL 616096December 10, 1999
K991829biostarCDTOX A OIANovember 2, 1999
K990664intracelPRIMA SYSTEM - OLD, BARTELS ELISA - NEWMarch 31, 1999