• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 029 Date of Entry 08/20/2012 
FR Recognition Number 7-76
Standard
CLSI M15-A (Replaces M15-T)
Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
Scope/Abstract
This document contains guidelines for specimen collection, blood film preparation, and staining procedures. Recommendations for optimum timing of specimen collection to assist laboratories in detecting, identifying and reporting certain parasites are also included.
Extent of Recognition
Complete standard
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 Contact
 Noel Gerald
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/
  301-796-4695
  noel.gerald@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.
-
-