Recognized standard
M34-A (Replaces M24-P)
FDA recognition 7-180 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-180 |
|---|---|
| Designation | M34-A (Replaces M24-P) |
| Title | Western Blot Assay for Antibodies to Borrelia burgdorferi; 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 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. |
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: