FDA source snapshot entry
Lyme Disease Antibodies (borrelia Burgdorferi Abs): analyte-level snapshot.
LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS) appeared in the FDA analyte source captured by WaivedLab on 2026-08-13. This entry preserves that dated label; it is not a current device-status determination.
Source retrieved 2026-08-13 · refresh due 2026-09-13
This page does not confirm that any Lyme Disease Antibodies (borrelia Burgdorferi Abs) kit or system is waived. Verify the exact manufacturer, product, model, specimen, intended use, and current official evidence manually before filing, purchasing, advertising, or testing.
What this snapshot does—and does not—show
- The snapshot stores an analyte label, not a product catalog entry or current complexity determination.
- LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS) alone cannot establish the status of a specific kit, instrument, cartridge, method, specimen, or intended use.
- A human must verify the exact system against current official evidence and confirm the clinic's current state route before filing.
Before including a system in a filing
Record the exact test-kit or system name, manufacturer, model or catalog identifier, specimen, and intended use. WaivedLab performs an administrative check of that system against current official evidence and confirms the current agency terminology, form, filing channel, signatures, and fees for the clinic's state before a final scope or price is shown. Professional judgment, when needed, is a separate engagement.
Check my test menuCLIA waiver requirements by state →