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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 021 FR Publication Date: 03/18/2009 

Part B: Supplementary Information

Recognition Number 07-145: CLSI H42-A2, enumeration of immunologically defined cell populations by flow cytometry. (InVitro Diagnostics)

Date of Standard: 2007. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
DEVICES THAT UTILIZE FLOW CYTOMETRY METHODOLOGY AND DEVICES INTENDED FOR LYMPHOCYTE IMMUNOPHENOTYPING BY FLOW CYTOMETRY.
Processes Affected:
510(K), PMA, IDE, PDP
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.5220 Counter, Differential Cell Class 2 GKZ
Relevant Guidance:
Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA
FDA Technical Contact:
 Josephine Bautista
  FDA/CDRH/OIVD
  2098 GAITHER ROAD, HFZ-440
  ROCKVILLE MD 20850
  240/276-0847
  email: josephine.bautista@fda.hhs.gov
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