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

FDA 510(k) Cleared Reagents, Clostridium Difficile Toxin Devices (Product Code LLH)

42 devices
1–24 of 42
Cleared Jul 08, 2021
SensiTox C. difficile Toxin Test
K193490
First Light Diagnostics, Inc.
Microbiology · 569d
Cleared Dec 21, 2010
OSOM C. DIFFICILE TOXIN A/B TEST
K102242
Genzyme Corporation
Microbiology · 134d
Cleared Jul 09, 2009
XPERT C. DIFFICILE
K091109
Cepheid
Microbiology · 84d
Cleared Apr 16, 2009
PROGASTRO CD ASSAY
K090239
Prodesse, Inc.
Microbiology · 73d
Cleared Mar 26, 2009
C. DIFF QUIK CHEK COMPLETE
K082499
Techlab, Inc.
Microbiology · 209d
Cleared Dec 19, 2008
BD GENEOHM CDIFF ASSAY
K081920
Bd Diagnostics (Geneohm Sciences, Inc.)
Microbiology · 169d
Cleared Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931
bioMerieux, Inc.
Microbiology · 70d
Cleared Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138
bioMerieux, Inc.
Microbiology · 141d
Cleared Jul 25, 2005
TOX A/B QUICK CHEK
K050891
Techlab, Inc.
Microbiology · 108d
Cleared Nov 15, 2004
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
K041951
Remel, Inc.
Microbiology · 118d
Cleared Aug 20, 2004
IMMUNOCARD TOXINS A & B, MODEL 712050
K041003
Meridian Bioscience, Inc.
Microbiology · 123d
Cleared Feb 26, 2004
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479
Remel, Inc.
Microbiology · 115d
Cleared Jul 11, 2003
C. DIFF CHEK - 30
K030991
Techlab, Inc.
Microbiology · 105d
Cleared Jul 11, 2003
C. DIFF CHEK - 60
K030992
Techlab, Inc.
Microbiology · 105d
Cleared Apr 24, 2003
C. DIFFICILE TOX A/B II
K030404
Techlab, Inc.
Microbiology · 77d
Cleared Nov 22, 2000
C. DIFFICILE TOX A/B II
K003306
Techlab, Inc.
Microbiology · 33d
Cleared Dec 10, 1999
PREMIER TOXINS A&B, MODEL 616096
K993914
Meridian Diagnostics, Inc.
Microbiology · 23d
Cleared Nov 02, 1999
CDTOX A OIA
K991829
Biostar, Inc.
Microbiology · 158d
Cleared Mar 31, 1999
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
K990664
Intracel Corp.
Microbiology · 30d
Cleared Jul 17, 1998
COLORPAC TOXIN A
K980185
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 178d
Cleared Jul 22, 1997
TOX A/B TEST
K971182
Techlab, Inc.
Microbiology · 113d
Cleared Apr 08, 1997
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887
Biomerieux Vitek, Inc.
Microbiology · 123d
Cleared Feb 04, 1997
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
K964864
Alexon Biomedical, Inc.
Microbiology · 62d
Cleared Apr 18, 1996
IMMUNOCARD TOXIN A
K955859
Meridian Diagnostics, Inc.
Microbiology · 113d

About Product Code LLH - Regulatory Context