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 Apr 26, 1994
CLOSTRIDIUM DIFFICILE TOX-B TEST
K935296
Techlab, Inc.
Microbiology · 174d
Cleared Sep 30, 1993
TECHLAB 1-HOUR TOX-A-TEST
K931129
Techlab, Inc.
Microbiology · 209d
Cleared Mar 24, 1993
CULTURETTE BRAND TOXIN CD TEST
K925329
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 154d
Cleared Feb 01, 1993
CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT
K923463
Techlab, Inc.
Microbiology · 202d
Cleared Jan 27, 1993
PREMIER C. DIFFICILE, MODIFICATION
K926442
Meridian Diagnostics, Inc.
Microbiology · 42d
Cleared Jan 26, 1993
IMMUNOCARD(TM) C. DIFFICILE
K924979
Meridian Diagnostics, Inc.
Microbiology · 117d
Cleared Oct 19, 1992
PREMIER C. DIFFICILE TOXIN A CONTROLS
K924136
Meridian Diagnostics, Inc.
Chemistry · 62d
Cleared Mar 04, 1992
CLOSTRIDIUM DIFFICILE TOX-A-TEST
K914902
Techlab, Inc.
Microbiology · 124d
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 Oct 25, 1988
CDT CYTOTOXI TEST
K883560
Advanced Clinical Diagnostics
Microbiology · 67d
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