LLH · Class I · 21 CFR 866.2660

FDA Product Code LLH: Reagents, Clostridium Difficile Toxin

Leading manufacturers include Techlab, Inc., Meridian Diagnostics, Inc. and Marion Laboratories, Inc..

42
Total
42
Cleared
130d
Avg days
1985
Since
42 devices
25–42 of 42
Cleared Oct 11, 1991
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
K905211
Vitek Systems, Inc.
Microbiology · 325d
Cleared Aug 29, 1991
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
K913229
Baxter Diagnostics, Inc.
Microbiology · 38d
Cleared Oct 01, 1990
PREMIER-C. DIFFICILE TOXIN A
K903456
Meridian Diagnostics, Inc.
Toxicology · 61d
Cleared Apr 14, 1987
CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST
K870864
Marion Laboratories, Inc.
Microbiology · 42d
Cleared Sep 17, 1986
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
K863485
Marion Laboratories, Inc.
Microbiology · 8d
Cleared Jul 19, 1985
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
K852044
Marion Laboratories, Inc.
Microbiology · 71d