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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 Entry 03/18/2009 
FR Recognition Number 7-173
Standard
CLSI C44-A (Replaces C44-P)
Harmonization of Glycohemoglobin Measurements; Approved Guideline
Scope/Abstract
This document describes an established program to harmonize glycohemoglobin (GHB) testing results among laboratories to a common, outcomes-based reference system and includes recommendations for the clinical application of harmonized GHB testing results.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.7470 Assay, Glycosylated Hemoglobin Class 2 LCP
FDA Technical Contact
 Yung Chan
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/
  301-796-6138
  yung.chan@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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