| CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
| Recognition Date | 2009-03-18 |
| Recognition List | 021 |
| Recognition Number | 7-180 |
| 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 document addresses technical and interpretive considerations for use of Western blot assays that detect antibodies to Borrelia burgdorferi and other Borrelia species that cause Lyme Disease.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.3830 | Reagent, Borrelia Serological Reagent | Class 2 | LSR |
| There is no relevant guidance developed at this time. |