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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 021 Date of Recognition 03/18/2009 
FR Recognition Number 7-71
Standard
CLSI H15-A3 (Replaces H15-A2)
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
Scope/Abstract
This document describes the principle, materials, and procedure for reference and standardized hemoglobin determinations. It includes specifications for secondary hemiglobincyanide (HiCN) standards.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§864.8165 Calibrator For Hemoglobin And Hematocrit Measurement Class 2 KRZ
§864.5620 System, Hemoglobin, Automated Class 2 GKR
§864.5200 Counter, Cell, Automated (Particle Counter) Class 2 GKL
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Niquiche Guity
  OMPT/CDRH/OIR/DIHD/HEMB
  240-402-6606
  Niquiche.Guity@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
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