Recognized standard
M36-A
FDA recognition 7-182 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-182 |
|---|---|
| Designation | M36-A |
| Title | Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 18, 2009 |
| Device classes | Class 2 |
| Scope (excerpt) | This guideline provides the user with information about the biology of Toxoplasma gondii, the methods available for use in the laboratory diagnosis of human toxoplasmosis, techniques that should be performed for specific clinical situations, and how to interpret laboratory results. |
At a glance
- 1–9 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: