Recognized standard
M53-A (Replaces M53-P)
FDA recognition 7-227 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-227 |
|---|---|
| Designation | M53-A (Replaces M53-P) |
| Title | Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 16, 2012 |
| Scope (excerpt) | This 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. |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: