Reagents, Clostridium Difficile Toxin

FDA product code LLH · 42 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.2660
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1985-07-19 – 2021-07-08

LLH 2021-07-08

SensiTox C. difficile Toxin Test

Applicant First Light Diagnostics, Inc.

K number K193490

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LLH 2010-12-21

OSOM C. DIFFICILE TOXIN A/B TEST

Applicant Genzyme Corporation

K number K102242

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LLH 2009-07-09

XPERT C. DIFFICILE

Applicant Cepheid

K number K091109

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LLH 2009-04-16

PROGASTRO CD ASSAY

Applicant Prodesse, Inc.

K number K090239

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LLH 2009-03-26

C. DIFF QUIK CHEK COMPLETE

Applicant Techlab, Inc.

K number K082499

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LLH 2008-12-19

BD GENEOHM CDIFF ASSAY

Applicant Bd Diagnostics (Geneohm Sciences, Inc.)

K number K081920

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LLH 2008-06-11

VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY

Applicant bioMerieux, Inc.

K number K080931

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LLH 2007-12-21

VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118

Applicant bioMerieux, Inc.

K number K072138

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LLH 2005-07-25

TOX A/B QUICK CHEK

Applicant Techlab, Inc.

K number K050891

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LLH 2004-11-15

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B

Applicant Remel, Inc.

K number K041951

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LLH 2004-08-20

IMMUNOCARD TOXINS A & B, MODEL 712050

Applicant Meridian Bioscience, Inc.

K number K041003

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LLH 2004-05-27

C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96

Applicant Ivd Research, Inc.

K number K032897

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LLH 2004-02-26

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

Applicant Remel, Inc.

K number K033479

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LLH 2003-07-11

C. DIFF CHEK - 60

Applicant Techlab, Inc.

K number K030992

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LLH 2003-07-11

C. DIFF CHEK - 30

Applicant Techlab, Inc.

K number K030991

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LLH 2003-04-24

C. DIFFICILE TOX A/B II

Applicant Techlab, Inc.

K number K030404

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LLH 2000-11-22

C. DIFFICILE TOX A/B II

Applicant Techlab, Inc.

K number K003306

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LLH 1999-12-10

PREMIER TOXINS A&B, MODEL 616096

Applicant Meridian Diagnostics, Inc.

K number K993914

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LLH 1999-11-02

CDTOX A OIA

Applicant Biostar, Inc.

K number K991829

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LLH 1999-03-31

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW

Applicant Intracel Corp.

K number K990664

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LLH 1998-07-17

COLORPAC TOXIN A

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K980185

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LLH 1997-07-22

TOX A/B TEST

Applicant Techlab, Inc.

K number K971182

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LLH 1997-04-08

VIDAS C. DIFFICILE TOXIN A II ASSAY

Applicant Biomerieux Vitek, Inc.

K number K964887

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LLH 1997-02-04

PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY

Applicant Alexon Biomedical, Inc.

K number K964864

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LLH 1996-04-18

IMMUNOCARD TOXIN A

Applicant Meridian Diagnostics, Inc.

K number K955859

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LLH 1994-09-20

PROSPECT MICROPLATE ASSAY

Applicant Alexon, Inc.

K number K934493

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LLH 1994-04-26

CLOSTRIDIUM DIFFICILE TOX-B TEST

Applicant Techlab, Inc.

K number K935296

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LLH 1993-09-30

TECHLAB 1-HOUR TOX-A-TEST

Applicant Techlab, Inc.

K number K931129

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LLH 1993-03-24

CULTURETTE BRAND TOXIN CD TEST

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K925329

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LLH 1993-02-01

CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT

Applicant Techlab, Inc.

K number K923463

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LLH 1993-01-27

PREMIER C. DIFFICILE, MODIFICATION

Applicant Meridian Diagnostics, Inc.

K number K926442

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LLH 1993-01-26

IMMUNOCARD(TM) C. DIFFICILE

Applicant Meridian Diagnostics, Inc.

K number K924979

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LLH 1992-10-19

PREMIER C. DIFFICILE TOXIN A CONTROLS

Applicant Meridian Diagnostics, Inc.

K number K924136

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LLH 1992-03-04

CLOSTRIDIUM DIFFICILE TOX-A-TEST

Applicant Techlab, Inc.

K number K914902

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LLH 1991-10-11

VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

Applicant Vitek Systems, Inc.

K number K905211

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LLH 1991-08-29

BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN

Applicant Baxter Diagnostics, Inc.

K number K913229

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LLH 1991-07-30

CYTOCLONE A & B EIA

Applicant Cambridge Biotech Corp.

K number K911958

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LLH 1990-10-01

PREMIER-C. DIFFICILE TOXIN A

Applicant Meridian Diagnostics, Inc.

K number K903456

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LLH 1988-10-25

CDT CYTOTOXI TEST

Applicant Advanced Clinical Diagnostics

K number K883560

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LLH 1987-04-14

CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST

Applicant Marion Laboratories, Inc.

K number K870864

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LLH 1986-09-17

MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST

Applicant Marion Laboratories, Inc.

K number K863485

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LLH 1985-07-19

CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI

Applicant Marion Laboratories, Inc.

K number K852044

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