Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Mardx Diagnostics with 8 510(k) clearances. The most recent is a 510(k) clearance dated Apr 8, 1997: MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM.
| Date | Record | Source |
|---|---|---|
| Apr 8, 1997 | MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEMK964787 · LLL | 510(k) clearances |
| Jun 7, 1996 | MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEMK951709 · LSR | 510(k) clearances |
| Jun 5, 1996 | MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEMK950829 · LSR | 510(k) clearances |
| Mar 20, 1996 | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEMK960182 · LRM | 510(k) clearances |
| Aug 21, 1989 | MARDX LYME DISEASE EIA (IGM) TEST SYSTEMK894293 · LSR | 510(k) clearances |
| Aug 21, 1989 | MARDX LYME DISEASE EIA (IGG) TEST SYSTEMK894224 · LSR | 510(k) clearances |
| Aug 15, 1989 | MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEMK892206 · LSR | 510(k) clearances |
| Apr 18, 1989 | MARDX LYME DISEASE IGG IFA TEST SYSTEMK890053 · LSR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
