Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a

• • Terminated Z-1352-2008 FDA Unclassified (pre-2012) ·initiated 4 Dec 2007

  False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.

510(k) Number

K974881 ↗

FDA Product Code

MCB

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Biosite Triage Panel For Drugs Of Abuse (50NG/ML)

  Class II

  FDA 510(k) K931598 Active Cleared 12 May 1993

• Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I

  Class II

  FDA 510(k) K973126 Active Cleared 6 Oct 1997

• Modification to Triage B-Type Natriuretic Peptide (Bnp) Test

  Class II

  FDA 510(k) K032235 Active Cleared 28 Jan 2004

• One Step Eddp (Methadone Metabolite) Test Strip

  Class II

  FDA 510(k) K092048 Active Cleared 19 Apr 2010

• Biosite Diagnostics Opiate Screening Test

  Class II

  FDA 510(k) K902924 Active Cleared 14 Sep 1990

• Triage Tox Drug Screen, Catalog #94000

  Class II

  FDA 510(k) K012745 Active Cleared 10 Jan 2002

See all devices from Biosite Incorporated →