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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 7-148: CLSI M28-A2, procedures for the recovery and identification of parasites from the intestinal tract; approved guideline - second edition. (InVitro Diagnostics)

Date of Standard: 2005. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
IVDs
Processes Affected:
510(K), IDE, PDP
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.3220 Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Class 2 KHW
§866.3220 Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. Class 2 GMO
§866.3220 Cryptosporidium Spp. Class 2 MHJ
§866.3220 Giardia Spp. Class 2 MHI
§866.3220 Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp Class 2 GWD
FDA Technical Contact:
 Noel Gerald
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 3650
  Silver Spring MD 20993
  301/796-4695
  email: noel.gerald@fda.hhs.gov
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