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MARDX DIAGNOSTICS, INC.

Last updated May 24, 2026

Information

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Trinity Biotech	1206631	FDA UDI	Class I	Active
Trinity Biotech	20-04648	FDA UDI	Class I	Active
Trinity Biotech	30-7120	FDA UDI	Class II	Active
TrinityBiotech	1206620	FDA UDI	Class II	Active
Trinity Biotech	31-8202	FDA UDI	Class II	Active
Trinity Biotech	30-7109	FDA UDI	Class II	Active
Trinity Biotech	20-04002	FDA UDI	Class I	Active
Trinity Biotech	40-2021L	FDA UDI	Class II	Active
Trinity Biotech	10-5848	FDA UDI	N	Active
Trinity Biotech	41-9002	FDA UDI	Class I	Active
Trinity Biotech	10-5404	FDA UDI	N	Active
Trinity Biotech	30-1527	FDA UDI	Class II	Active
Trinity Biotech	30-1524	FDA UDI	Class II	Active
Trinity Biotech	30-7104	FDA UDI	Class II	Active
Mardx Lyme Disease Eia (igg) Test System	K894224	FDA 510(k)	Class II	Active
Mardx Lyme Disease (igg) Marblot Strip Test System	K950829	FDA 510(k)	Class II	Active
Mardx Lyme Disease Igg Ifa Test System	K890053	FDA 510(k)	Class II	Active
Dsdna Immunoglobulin Eia Test System	K960182	FDA 510(k)	Class II	Active
Mardx Lyme Disease Eia (igm) Test System	K894293	FDA 510(k)	Class II	Active
Mardx Llyme Disease Eia (igg & Igm) Test System	K892206	FDA 510(k)	Class II	Active
Mardx Lyme Disease (igm) Marblot Strip Test System	K951709	FDA 510(k)	Class II	Active
Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test System	K964787	FDA 510(k)	Class II	Active

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