Product code LLH
- Device name
- Reagents, Clostridium Difficile Toxin
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193490 | SensiTox C. difficile Toxin Test | First Light Diagnostics, Inc. | 2021-07-08 |
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | Genzyme Corporation | 2010-12-21 |
| K091109 | XPERT C. DIFFICILE | Cepheid | 2009-07-09 |
| K090239 | PROGASTRO CD ASSAY | Prodesse, Inc. | 2009-04-16 |
| K082499 | C. DIFF QUIK CHEK COMPLETE | Techlab, Inc. | 2009-03-26 |
| K081920 | BD GENEOHM CDIFF ASSAY | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008-12-19 |
| K080931 | VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY | bioMerieux, Inc. | 2008-06-11 |
| K072138 | VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 | bioMerieux, Inc. | 2007-12-21 |
| K050891 | TOX A/B QUICK CHEK | Techlab, Inc. | 2005-07-25 |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | Remel, Inc. | 2004-11-15 |
| K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 | Meridian Bioscience, Inc. | 2004-08-20 |
| K032897 | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 | Ivd Research, Inc. | 2004-05-27 |
| K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | Remel, Inc. | 2004-02-26 |
| K030991 | C. DIFF CHEK - 30 | Techlab, Inc. | 2003-07-11 |
| K030992 | C. DIFF CHEK - 60 | Techlab, Inc. | 2003-07-11 |
| K030404 | C. DIFFICILE TOX A/B II | Techlab, Inc. | 2003-04-24 |
| K003306 | C. DIFFICILE TOX A/B II | Techlab, Inc. | 2000-11-22 |
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | Meridian Diagnostics, Inc. | 1999-12-10 |
| K991829 | CDTOX A OIA | Biostar, Inc. | 1999-11-02 |
| K990664 | PRIMA SYSTEM - OLD, BARTELS ELISA - NEW | Intracel Corp. | 1999-03-31 |
| K980185 | COLORPAC TOXIN A | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-07-17 |
| K971182 | TOX A/B TEST | Techlab, Inc. | 1997-07-22 |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Biomerieux Vitek, Inc. | 1997-04-08 |
| K964864 | PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1997-02-04 |
| K955859 | IMMUNOCARD TOXIN A | Meridian Diagnostics, Inc. | 1996-04-18 |
| K934493 | PROSPECT MICROPLATE ASSAY | Alexon, Inc. | 1994-09-20 |
| K935296 | CLOSTRIDIUM DIFFICILE TOX-B TEST | Techlab, Inc. | 1994-04-26 |
| K931129 | TECHLAB 1-HOUR TOX-A-TEST | Techlab, Inc. | 1993-09-30 |
| K925329 | CULTURETTE BRAND TOXIN CD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-03-24 |
| K923463 | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT | Techlab, Inc. | 1993-02-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033891322779 | CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS | DIESSE DIAGNOSTICA SENESE SPA | 2025-08-19 |
| 05032384519828 | ProSpecT™ Wash Buffer | OXOID LIMITED | 2024-07-05 |
| 05032384519903 | ProSpecT C. difficile Toxin A/B Microplate | OXOID LIMITED | 2022-12-23 |
| 06974849369229 | Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2022-12-06 |
| 06974849369236 | Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2022-12-06 |
| 00848838068416 | Remel | REMEL, INC. | 2022-04-21 |
| 30848838027094 | Remel | REMEL, INC. | 2022-04-21 |
| 30848838068417 | Remel | REMEL, INC. | 2022-04-21 |
| 00848838027093 | Remel | REMEL, INC. | 2022-04-21 |
| 00857031002646 | C. DIFFICILE TOX A/B II | TECHLAB, INC. | 2021-05-07 |
| 00857031002660 | C. DIFF CHEK - 60 | TECHLAB, INC. | 2021-05-03 |
| 00840733101786 | ImmunoCard Toxins A & B | MERIDIAN BIOSCIENCE, INC. | 2020-09-21 |
| 00840733101694 | PREMIER Toxins A and B | MERIDIAN BIOSCIENCE, INC. | 2020-09-01 |
| 00857031002264 | C. DIFFICILE TOX-B TEST | TECHLAB, INC. | 2020-01-24 |
| 00857031002066 | C. DIFFICILE TOXIN ANTITOXIN KIT | TECHLAB, INC. | 2020-01-24 |
| 00857031002073 | C. DIFFICILE TOX-B TEST | TECHLAB, INC. | 2020-01-24 |
| 03573026229146 | VIDAS® C. difficile Toxin A & B | BIOMERIEUX SA | 2019-11-08 |
| 00857031002554 | C. DIFF QUIK CHEK COMPLETE | TECHLAB, INC. | 2019-05-31 |
| 00857031002448 | C. DIFF CHEK - 60 | TECHLAB, INC. | 2019-05-31 |
| 00857031002431 | C. DIFFICILE TOX A/B II | TECHLAB, INC. | 2019-05-31 |
| 00857031002110 | C. DIFF CHEK - 60 | TECHLAB, INC. | 2019-04-12 |
| 00857031002219 | C. DIFFICILE TOX A/B II | TECHLAB, INC. | 2019-04-12 |
| 00857031002226 | C. DIFF CHEK - 60 | TECHLAB, INC. | 2019-04-12 |
| 00857031002042 | TOX A/B QUIK CHEK | TECHLAB, INC. | 2018-08-07 |
| 00857031002059 | C. DIFF QUIK CHEK COMPLETE | TECHLAB, INC. | 2018-08-07 |
| 07332940000035 | Xpert C. difficile | CEPHEID | 2018-01-29 |
| 07332940000059 | Xpert C. difficile | CEPHEID | 2018-01-29 |
| 05391516748773 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 05391516748780 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 15420045506350 | PRODESSE | Hologic, Inc. | 2016-04-15 |