• 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 036 Date of Recognition 07/09/2014 
FR Recognition Number 7-175
Standard
CLSI C59-A
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
Scope/Abstract
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
  FDA/OMPT/CDRH/OIR/DCTD/CRDB/
  301-796-6160
  paula.caposino@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
-
-