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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 021 FR Publication Date: 03/18/2009 

Part B: Supplementary Information

Recognition Number 7-175: CLSI I/LA15-A, apoplipoprotein immunoassays: development and recommended performance characteristics; approved guideline. (InVitro Diagnostics)

Date of Standard: 1997. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Chemistry, Immunology
Processes Affected:
510(k)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1475 Apolipoproteins Class 1 MSJ
§866.5580 Alpha-1-Lipoprotein, Antigen, Antiserum, Control Class 2 DER
§866.5600 Lipoprotein, Low-Density, Antigen, Antiserum, Control Class 2 DFC
FDA Technical Contact:
 Ruth Chesler
  FDA/CDRH/OIVD
  2098 Gaither Road, HFZ-440
  Rockville MD 20850
  240/276-0686
  email: ruth.chesler@fda.hhs.gov
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