LLH · Reagents, Clostridium Difficile Toxin
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | LLH |
|---|---|
| Device Name | Reagents, Clostridium Difficile Toxin |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K193490 | SensiTox C. difficile Toxin Test | First Light Diagnostics, Inc. | Jul 8, 2021 | SESE |
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | Genzyme Corporation | Dec 21, 2010 | SESE |
| K091109 | XPERT C. DIFFICILE | Cepheid | Jul 9, 2009 | SESE |
| K090239 | PROGASTRO CD ASSAY | Prodesse, Inc. | Apr 16, 2009 | SESE |
| K082499 | C. DIFF QUIK CHEK COMPLETE | Techlab, Inc. | Mar 26, 2009 | SESE |
| K081920 | BD GENEOHM CDIFF ASSAY | Bd Diagnostics (Geneohm Sciences, Inc.) | Dec 19, 2008 | SESE |
| K080931 | VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY | bioMerieux, Inc. | Jun 11, 2008 | SESE |
| K072138 | VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 | bioMerieux, Inc. | Dec 21, 2007 | SESE |
| K050891 | TOX A/B QUICK CHEK | Techlab, Inc. | Jul 25, 2005 | SESE |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | Remel, Inc. | Nov 15, 2004 | SESE |
| K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 | Meridian Bioscience, Inc. | Aug 20, 2004 | SESE |
| K032897 | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 | Ivd Research, Inc. | May 27, 2004 | SESE |
| K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | Remel, Inc. | Feb 26, 2004 | SESE |
| K030992 | C. DIFF CHEK - 60 | Techlab, Inc. | Jul 11, 2003 | SESE |
| K030991 | C. DIFF CHEK - 30 | Techlab, Inc. | Jul 11, 2003 | SESE |
| K030404 | C. DIFFICILE TOX A/B II | Techlab, Inc. | Apr 24, 2003 | SESE |
| K003306 | C. DIFFICILE TOX A/B II | Techlab, Inc. | Nov 22, 2000 | SESE |
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | Meridian Diagnostics, Inc. | Dec 10, 1999 | SESE |
| K991829 | CDTOX A OIA | Biostar, Inc. | Nov 2, 1999 | SESE |
| K990664 | PRIMA SYSTEM - OLD, BARTELS ELISA - NEW | Intracel Corp. | Mar 31, 1999 | SESE |
Top Applicants
- Techlab, Inc. — 11 clearances
- Meridian Diagnostics, Inc. — 6 clearances
- Marion Laboratories, Inc. — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Remel, Inc. — 2 clearances
