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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 029 Date of Entry 08/20/2012 
FR Recognition Number 7-148
CLSI  M28-A2 (Replaces M28-A)
Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
This guideline addresses the collection, processing, and examination of intestinal tract specimens for the identification of parasites.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.3220 Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. Class 2 GMO
§866.3220 Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp Class 2 GWD
§866.3220 Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Class 2 KHW
§866.3220 Giardia Spp. Class 2 MHI
§866.3220 Cryptosporidium Spp. Class 2 MHJ
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
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.