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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 023 Date of Entry 05/05/2010 
FR Recognition Number 7-207
Standard
CLSI GP16-A3 (Replaces GP16-A2)
Urinalysis; Approved Guideline - Third Edition
Scope/Abstract
This document addresses procedures for testing urine, including materials and equipment; macroscopic/physical evaluation; chemical analysis; and microscopic analysis.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 862 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
21 CFR 864 HEMATOLOGY AND PATHOLOGY DEVICES
21 CFR 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Tamara Pinkney
  FDA/OC/CDRH/OPEQ/OIDRH/DPOM/
  301-796-6182
  tamara.pinkney@fda.hhs.gov
 Sharmila Shrestha
  FDA/OC/CBER/OBRR/DBCD/DRB/
  240-402-6065
  Sharmila.Shrestha@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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