Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
028
|
Date of Entry 03/16/2012
|
FR Recognition Number
|
7-227
|
Standard | |
CLSI M53-A (Replaces M53-P) Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
|
Scope/AbstractThis document provides an extensive review of existing laboratory methods commonly used to test for HIV infection. This guideline also offers recommendations for how to best use and interpret these tests accurately and effectively to diagnose HIV infection. |
|
Extent of Recognition
|
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
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |