Atlas FDA

LLH

42 FDA 510(k) clearances · Product code

113 daysmedian time to decision
209 days90th percentile
42clearances measured

FDA profile

Official device name
Reagents, Clostridium Difficile Toxin
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Medical specialty
Microbiology
Adverse events (MAUDE)
1994: 1 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SensiTox C. difficile Toxin Test (K193490)First Light Diagnostics, Inc.2021-07-08
OSOM C. DIFFICILE TOXIN A/B TEST (K102242)Genzyme Corporation2010-12-21
XPERT C. DIFFICILE (K091109)Cepheid2009-07-09
PROGASTRO CD ASSAY (K090239)Prodesse, Inc.2009-04-16
C. DIFF QUIK CHEK COMPLETE (K082499)Techlab, Inc.2009-03-26
BD GENEOHM CDIFF ASSAY (K081920)Bd Diagnostics (Geneohm Sciences, Inc.)2008-12-19
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (K080931)bioMerieux, Inc.2008-06-11
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (K072138)bioMerieux, Inc.2007-12-21
TOX A/B QUICK CHEK (K050891)Techlab, Inc.2005-07-25
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (K041951)Remel, Inc.2004-11-15
IMMUNOCARD TOXINS A & B, MODEL 712050 (K041003)Meridian Bioscience, Inc.2004-08-20
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 (K032897)Ivd Research, Inc.2004-05-27
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (K033479)Remel, Inc.2004-02-26
C. DIFF CHEK - 60 (K030992)Techlab, Inc.2003-07-11
C. DIFF CHEK - 30 (K030991)Techlab, Inc.2003-07-11
C. DIFFICILE TOX A/B II (K030404)Techlab, Inc.2003-04-24
C. DIFFICILE TOX A/B II (K003306)Techlab, Inc.2000-11-22
PREMIER TOXINS A&B, MODEL 616096 (K993914)Meridian Diagnostics, Inc.1999-12-10
CDTOX A OIA (K991829)Biostar, Inc.1999-11-02
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW (K990664)Intracel Corp.1999-03-31
COLORPAC TOXIN A (K980185)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-07-17
TOX A/B TEST (K971182)Techlab, Inc.1997-07-22
VIDAS C. DIFFICILE TOXIN A II ASSAY (K964887)Biomerieux Vitek, Inc.1997-04-08
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY (K964864)Alexon Biomedical, Inc.1997-02-04
IMMUNOCARD TOXIN A (K955859)Meridian Diagnostics, Inc.1996-04-18
PROSPECT MICROPLATE ASSAY (K934493)Alexon, Inc.1994-09-20
CLOSTRIDIUM DIFFICILE TOX-B TEST (K935296)Techlab, Inc.1994-04-26
TECHLAB 1-HOUR TOX-A-TEST (K931129)Techlab, Inc.1993-09-30
CULTURETTE BRAND TOXIN CD TEST (K925329)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-03-24
CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT (K923463)Techlab, Inc.1993-02-01
PREMIER C. DIFFICILE, MODIFICATION (K926442)Meridian Diagnostics, Inc.1993-01-27
IMMUNOCARD(TM) C. DIFFICILE (K924979)Meridian Diagnostics, Inc.1993-01-26
PREMIER C. DIFFICILE TOXIN A CONTROLS (K924136)Meridian Diagnostics, Inc.1992-10-19
CLOSTRIDIUM DIFFICILE TOX-A-TEST (K914902)Techlab, Inc.1992-03-04
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY (K905211)Vitek Systems, Inc.1991-10-11
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN (K913229)Baxter Diagnostics, Inc.1991-08-29
CYTOCLONE A & B EIA (K911958)Cambridge Biotech Corp.1991-07-30
PREMIER-C. DIFFICILE TOXIN A (K903456)Meridian Diagnostics, Inc.1990-10-01
CDT CYTOTOXI TEST (K883560)Advanced Clinical Diagnostics1988-10-25
CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST (K870864)Marion Laboratories, Inc.1987-04-14
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST (K863485)Marion Laboratories, Inc.1986-09-17
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI (K852044)Marion Laboratories, Inc.1985-07-19

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Every clearance here is in the API, with alerts when new ones post.