Reagents, Clostridium Difficile Toxin
FDA product code LLH · Class I (low risk) · 21 CFR 866.2660 · Microbiology
42510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Techlab, Inc. 11
- Meridian Diagnostics, Inc. 6
- Marion Laboratories, Inc. 3
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Biomerieux Inc 2
- Remel Co. 2
- Biomerieux Vitek, Inc. 1
- First Light Diagnostics, Inc. 1
- Cepheid 1
- Prodesse, Inc. 1
- BD Diagnostics (GeneOhm Sciences, Inc) 1
- Meridian Bioscience, Inc. 1
- Ivd Research, Inc. 1
- Biostar, Inc. 1
- Intracel Corp. 1
- Alexon Biomedical, Inc. 1
- Alexon, Inc. 1
- Vitek Systems, Inc. 1
- Baxter Diagnostics, Inc. 1
- Cambridge Biotech Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193490 | SensiTox C. difficile Toxin TestLLH · Traditional | First Light Diagnostics, Inc. | 07/08/2021SE |
| K102242 | Osom C. Difficile Toxin A/B TestLLH · Traditional | Genzyme Corporation | 12/21/2010SE |
| K091109 | Xpert C. DifficileLLH · Traditional | Cepheid | 07/09/2009SE |
| K090239 | Progastro CD AssayLLH · Traditional | Prodesse, Inc. | 04/16/2009SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | Techlab, Inc. | 03/26/2009SE |
| K081920 | BD Geneohm Cdiff AssayLLH · Traditional | Bd Diagnostics (Geneohm Sciences, Inc.) | 12/19/2008SE |
| K080931 | Vidas C. Dificile Toxin a & B (Cdab) AssayLLH · Traditional | bioMerieux, Inc. | 06/11/2008SE |
| K072138 | Vidas C. Difficile Toxin A&B (Cdab) Assay, Model: 30 118LLH · Traditional | bioMerieux, Inc. | 12/21/2007SE |
| K050891 | Tox A/B Quick ChekLLH · Traditional | Techlab, Inc. | 07/25/2005SE |
| K041951 | Xpect Clostridium Difficile Toxin A/BLLH · Traditional | Remel, Inc. | 11/15/2004SE |
| K041003 | Immunocard Toxins a & B, Model 712050LLH · Traditional | Meridian Bioscience, Inc. | 08/20/2004SE |
| K032897 | C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; CDIFF-96LLH · Traditional | Ivd Research, Inc. | 05/27/2004SE |
| K033479 | Prospect Clostridium Difficile Toxin A/B Microplate AssayLLH · Traditional | Remel, Inc. | 02/26/2004SE |
| K030992 | C. Diff Chek - 60LLH · Traditional | Techlab, Inc. | 07/11/2003SE |
| K030991 | C. Diff Chek - 30LLH · Traditional | Techlab, Inc. | 07/11/2003SE |
| K030404 | C. Difficile Tox A/B IILLH · Traditional | Techlab, Inc. | 04/24/2003SE |
| K003306 | C. Difficile Tox A/B IILLH · Special | Techlab, Inc. | 11/22/2000SE |
| K993914 | Premier Toxins A&B, Model 616096LLH · Special | Meridian Diagnostics, Inc. | 12/10/1999SE |
| K991829 | Cdtox a OiaLLH · Traditional | Biostar, Inc. | 11/02/1999SE |
| K990664 | Prima System - Old, Bartels Elisa - NewLLH · Special | Intracel Corp. | 03/31/1999SE |
| K980185 | Colorpac Toxin aLLH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/17/1998SE |
| K971182 | Tox A/B TestLLH · Traditional | Techlab, Inc. | 07/22/1997SE |
| K964887 | Vidas C. Difficile Toxin a II AssayLLH · Traditional | Biomerieux Vitek, Inc. | 04/08/1997SE |
| K964864 | Prospect II Clostridium Diffillie Toxin a Microplate AssayLLH · Traditional | Alexon Biomedical, Inc. | 02/04/1997SE |
| K955859 | Immunocard Toxin aLLH · Traditional | Meridian Diagnostics, Inc. | 04/18/1996SE |
| K934493 | Prospect Microplate AssayLLH · Traditional | Alexon, Inc. | 09/20/1994SE |
| K935296 | Clostridium Difficile Tox-B TestLLH · Traditional | Techlab, Inc. | 04/26/1994SE |
| K931129 | Techlab 1-HOUR Tox-A-TestLLH · Traditional | Techlab, Inc. | 09/30/1993SE |
| K925329 | Culturette Brand Toxin CD TestLLH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/24/1993SE |
| K923463 | Clostridium Difficile Toxin/Antitoxin KitLLH · Traditional | Techlab, Inc. | 02/01/1993SE |
| K926442 | Premier C. Difficile, ModificationLLH · Traditional | Meridian Diagnostics, Inc. | 01/27/1993SE |
| K924979 | Immunocard(Tm) C. DifficileLLH · Traditional | Meridian Diagnostics, Inc. | 01/26/1993SE |
| K924136 | Premier C. Difficile Toxin a ControlsLLH · Traditional | Meridian Diagnostics, Inc. | 10/19/1992SE |
| K914902 | Clostridium Difficile Tox-A-TestLLH · Traditional | Techlab, Inc. | 03/04/1992SE |
| K905211 | Vidas Clostridium Difficile Toxin a (Cda) AssayLLH · Traditional | Vitek Systems, Inc. | 10/11/1991SE |
| K913229 | Bartels Clostridium Difficile Toxin a Enzym ImmunLLH · Traditional | Baxter Diagnostics, Inc. | 08/29/1991SE |
| K911958 | Cytoclone a & B EiaLLH · Traditional | Cambridge Biotech Corp. | 07/30/1991SE |
| K903456 | Premier-C. Difficile Toxin aLLH · Traditional | Meridian Diagnostics, Inc. | 10/01/1990SE |
| K883560 | CDT Cytotoxi TestLLH · Traditional | Advanced Clinical Diagnostics | 10/25/1988SE |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | Marion Laboratories, Inc. | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | Marion Laboratories, Inc. | 09/17/1986SE |
| K852044 | Culturette Brand Rapid Latex Test Clostridium ToxiLLH · Traditional | Marion Laboratories, Inc. | 07/19/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0425-2022 Class II | VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-0790-2014 Class II | BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200…An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved… | Becton Dickinson & Co. | 10/11/2013Terminated |
| Z-0015-2014 Class II | Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States)…Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin… | Sekisui Diagnostics LLC | 09/16/2013Terminated |
| Z-0807-2013 Class II | Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B…The firm is recalling the products due to a potential for false negative test results. | Remel Inc | 08/20/2012Terminated |
| Z-0806-2013 Class II | Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B…The firm is recalling the products due to a potential for false negative test results. | Remel Inc | 08/20/2012Terminated |
| Z-2319-2012 Class II | BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm…Leakage in Cepheid SmartCycler reaction tubes. | Becton Dickinson & Co. | 05/22/2012Terminated |
| Z-2318-2012 Class II | BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD…Leakage in Cepheid SmartCycler reaction tubes. | Becton Dickinson & Co. | 05/22/2012Terminated |
| Z-2316-2012 Class II | BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm…Leakage in Cepheid SmartCycler reaction tubes. | Becton Dickinson & Co. | 05/22/2012Terminated |
| Z-2174-2010 | BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD…In vitro diagnostic test kits do not perform to specifications. | Becton Dickinson & Co. | 03/05/2010Terminated |