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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 7-197: CLSI M35-A2, abbreviated identification of bacteria and yeast; approved guideline - second edition. (InVitro Diagnostics)

Date of Standard: 2008. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(3)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Microorganism differentiation and identification device regulated under 21 CFR 866.2660
Processes Affected:
510(k), pre-IDE
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.3310 Hepatitis A Test (Antibody And Igm Antibody) Class 2 LOL
§866.2660 Discs, Strips And Reagents, Microorganism Differentiation Class 1 JTO
§866.2660 Gram Negative Identification Panel Class 1 LQM
§866.2660 Instrument For Auto Reader Of Overnight Microorganism Identification System Class 1 LRH
§866.2660 Kit, Anaerobic Identification Class 1 JSP
§866.2660 Kit, Screening, Yeast Class 1 JXC
Relevant Guidance:
1. Review Criteria for Assessment of Antimicrobial Susceptibility Discs
2. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA
FDA Technical Contacts:
 Yvonne Shea
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5510
  Silver Spring MD 20993
  301/796-0576
  email: yvonne.shea@fda.hhs.gov
 Alexandra Wong
  FDA/CDRH/OIR
  10993 New Hampshire Avenue Building 66, Room 5502
  Silver Spring MD 20993
  301/796-6210
  email: alexandra.wong@fda.hhs.gov
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