| CLSI M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. |
| Recognition Date | 2009-03-18 |
| Recognition List | 021 |
| Recognition Number | 7-182 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Prasad Rao FDA/OMPT/CDRH/OIR/DMD/VIR2/ 301-796-6203 prasad.rao@fda.hhs.gov |
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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.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.3780 | Antigens, Cf, Toxoplasma Gondii | Class 2 | GMN |
| §866.3780 | Antigens, If, Toxoplasma Gondii | Class 2 | GLZ |
| §866.3780 | Antigens, Iha, Toxoplasma Gondii | Class 2 | GMM |
| §866.3780 | Antisera, If, Toxoplasma Gondii | Class 2 | LJK |
| §866.3780 | Direct Agglutination Test, Toxoplasma Gondii | Class 2 | LLA |
| §866.3780 | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | Class 2 | LGD |
| §866.3780 | Pneumocystis Carinii | Class 2 | LYF |
| There is no relevant guidance developed at this time. |