Recognized standard
M15-A (Replaces M15-T)
FDA recognition 7-76 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-76 |
|---|---|
| Designation | M15-A (Replaces M15-T) |
| Title | Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 20, 2012 |
| Scope (excerpt) | This document contains guidelines for specimen collection, blood film preparation, and staining procedures. Recommendations for optimum timing of specimen collection to assist laboratories in detecting, identifying and reporting certain parasites are also included. |
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: