FDA Product Code LLH: Reagents, Clostridium Difficile Toxin
Leading manufacturers include bioMerieux, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and First Light Diagnostics, Inc..
42
Total
42
Cleared
130d
Avg days
1985
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Reagents, Clostridium Difficile Toxin Devices (Product Code LLH)
42 devices
Cleared
Jul 08, 2021
SensiTox C. difficile Toxin Test
First Light Diagnostics, Inc.
Microbiology
569d
Cleared
Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
bioMerieux, Inc.
Microbiology
70d
Cleared
Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
bioMerieux, Inc.
Microbiology
141d
Cleared
Jul 17, 1998
COLORPAC TOXIN A
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology
178d
Cleared
Mar 24, 1993
CULTURETTE BRAND TOXIN CD TEST
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology
154d
About Product Code LLH - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code LLH since 1985, with 42 receiving FDA clearance (average review time: 130 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.