Panels › Microbiology › Product code LLH · Class 1
Reagents, Clostridium Difficile Toxin
Regulation 866.2660
0510(k)s in 12 months (42 all time)
0recalls in 12 months (11 all time)
8recalls that name a 510(k)
Top companies in LLH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2021 | K193490 | SensiTox C. difficile Toxin Test First Light Diagnostics, Inc. | LLH |
| Dec 21, 2010 | K102242 | OSOM C. DIFFICILE TOXIN A/B TEST Genzyme Corporation | LLH |
| Jul 9, 2009 | K091109 | XPERT C. DIFFICILE Cepheid | LLH |
| Apr 16, 2009 | K090239 | PROGASTRO CD ASSAY Prodesse, Inc. | LLH |
| Mar 26, 2009 | K082499 | C. DIFF QUIK CHEK COMPLETE Techlab, Inc. | LLH |
| Dec 19, 2008 | K081920 | BD GENEOHM CDIFF ASSAY Bd Diagnostics (Geneohm Sciences, Inc.) | LLH |
| Jun 11, 2008 | K080931 | VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY bioMerieux, Inc. | LLH |
| Dec 21, 2007 | K072138 | VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 bioMerieux, Inc. | LLH |
| Jul 25, 2005 | K050891 | TOX A/B QUICK CHEK Techlab, Inc. | LLH |
| Nov 15, 2004 | K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B Remel, Inc. | LLH |
| Aug 20, 2004 | K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 Meridian Bioscience, Inc. | LLH |
| May 27, 2004 | K032897 | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 Ivd Research, Inc. | LLH |
| Feb 26, 2004 | K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY Remel, Inc. | LLH |
| Jul 11, 2003 | K030992 | C. DIFF CHEK - 60 Techlab, Inc. | LLH |
| Jul 11, 2003 | K030991 | C. DIFF CHEK - 30 Techlab, Inc. | LLH |
| Apr 24, 2003 | K030404 | C. DIFFICILE TOX A/B II Techlab, Inc. | LLH |
| Nov 22, 2000 | K003306 | C. DIFFICILE TOX A/B II Techlab, Inc. | LLH |
| Dec 10, 1999 | K993914 | PREMIER TOXINS A&B, MODEL 616096 Meridian Diagnostics, Inc. | LLH |
| Nov 2, 1999 | K991829 | CDTOX A OIA Biostar, Inc. | LLH |
| Mar 31, 1999 | K990664 | PRIMA SYSTEM - OLD, BARTELS ELISA - NEW Intracel Corp. | LLH |
| Jul 17, 1998 | K980185 | COLORPAC TOXIN A Bd Becton Dickinson Vacutainer Systems Preanalytic | LLH |
| Jul 22, 1997 | K971182 | TOX A/B TEST Techlab, Inc. | LLH |
| Apr 8, 1997 | K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY Biomerieux Vitek, Inc. | LLH |
| Feb 4, 1997 | K964864 | PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY Alexon Biomedical, Inc. | LLH |
| Apr 18, 1996 | K955859 | IMMUNOCARD TOXIN A Meridian Diagnostics, Inc. | LLH |
| Sep 20, 1994 | K934493 | PROSPECT MICROPLATE ASSAY Alexon, Inc. | LLH |
| Apr 26, 1994 | K935296 | CLOSTRIDIUM DIFFICILE TOX-B TEST Techlab, Inc. | LLH |
| Sep 30, 1993 | K931129 | TECHLAB 1-HOUR TOX-A-TEST Techlab, Inc. | LLH |
| Mar 24, 1993 | K925329 | CULTURETTE BRAND TOXIN CD TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | LLH |
| Feb 1, 1993 | K923463 | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT Techlab, Inc. | LLH |
| Jan 27, 1993 | K926442 | PREMIER C. DIFFICILE, MODIFICATION Meridian Diagnostics, Inc. | LLH |
| Jan 26, 1993 | K924979 | IMMUNOCARD(TM) C. DIFFICILE Meridian Diagnostics, Inc. | LLH |
| Oct 19, 1992 | K924136 | PREMIER C. DIFFICILE TOXIN A CONTROLS Meridian Diagnostics, Inc. | LLH |
| Mar 4, 1992 | K914902 | CLOSTRIDIUM DIFFICILE TOX-A-TEST Techlab, Inc. | LLH |
| Oct 11, 1991 | K905211 | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY Vitek Systems, Inc. | LLH |
| Aug 29, 1991 | K913229 | BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN Baxter Diagnostics, Inc. | LLH |
| Jul 30, 1991 | K911958 | CYTOCLONE A & B EIA Cambridge Biotech Corp. | LLH |
| Oct 1, 1990 | K903456 | PREMIER-C. DIFFICILE TOXIN A Meridian Diagnostics, Inc. | LLH |
| Oct 25, 1988 | K883560 | CDT CYTOTOXI TEST Advanced Clinical Diagnostics | LLH |
| Apr 14, 1987 | K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST Marion Laboratories, Inc. | LLH |
| Sep 17, 1986 | K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST Marion Laboratories, Inc. | LLH |
| Jul 19, 1985 | K852044 | CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI Marion Laboratories, Inc. | LLH |
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