Rapid Yeast Plus System

• • Terminated Z-0530-2014 FDA Class II ·initiated 4 Apr 2013

  The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.

• • Terminated Z-0870-2010 FDA Unclassified (pre-2012) ·initiated 28 Oct 2009

  There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. The database erroneously includes Candida dubliniensis as well as displays an incorrect temperature range as an accessory test for codes with an overlap between Candida albicans and Candida dubliniensis. When using the

510(k) Number

K943621 ↗

FDA Product Code

JXB

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Ids Rapid Cb Plus System

  Class I

  FDA 510(k) K962966 Active Cleared 8 Oct 1996

• Ids Rapid Str System

  Class I

  FDA 510(k) K833654 Active Cleared 13 Feb 1984

• Ida Rapid O2A System

  Class I

  FDA 510(k) K820483 Active Cleared 15 Mar 1982

• Rapid Nf System

  Class I

  FDA 510(k) K900517 Active Cleared 13 Mar 1990

• Ids Rapid Ana System

  Class I

  FDA 510(k) K882960 Active Cleared 12 Aug 1988

• Ids Staphylochrome Test

  Class I

  FDA 510(k) K822144 Active Cleared 24 Aug 1982

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