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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 036 Date of Recognition 07/09/2014 
FR Recognition Number 7-175
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
This guideline describes the characterization and preparation of immunogens, antibodies, samples, and methods, and provides guidance for immunochemical testing of apolipoproteins.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§866.5600 Lipoprotein, Low-Density, Antigen, Antiserum, Control Class 2 DFC
§866.5580 Alpha-1-Lipoprotein, Antigen, Antiserum, Control Class 2 DER
§862.1475 Apolipoproteins Class 1 MSJ
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Paula Caposino
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics