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Immco Diagnostics, Inc.

United States·US-MF-000035173

Last updated September 17, 2026

About

Trinity Biotech plc is a public company, specialising in the development, manufacture and marketing of clinical diagnostic products. We are also a significant provider of raw materials to the life sciences industry.

From the manufacturer's own website. Source

Information

Country: United States
Address: 10, 10 Earhart Dr., Buffalo, United States
Website: www.trinitybiotech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +17166910091
PRRC Contact: Lee Kroening
EUDAMED SRN: US-MF-000035173
FDA FEI Number: 3015376545
DUNS Number: —

Catalogue (243)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Immulisa Mpo Antibody Elisa	K092599	FDA 510(k)	Class II	Active
Immulisa Enhanced Celiac Fusion (ttg/Dgp) Iga/Igg Antibody Elisa	K123713	FDA 510(k)	Class II	Active
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA	K142781	FDA 510(k)	Class II	Active
Immulisa Intrinsic Factor Antibody Elisa	K071346	FDA 510(k)	Class II	Active
Immulisa Dsdna Antibody Elisa	K101319	FDA 510(k)	Class II	Active
Anit-Ena Antibody Test [ss-B (la)]	K920384	FDA 510(k)	Class II	Active
Immulisa Celiac G+ (gliadin) Iga And Igg Antibody Elisa	K091522	FDA 510(k)	Class II	Active
Antinuclear Antibody (ana) Test (hep-2 Cells)	K883883	FDA 510(k)	Class II	Active
ImmuGlo HEp-2 Elite IFA	K172745	FDA 510(k)	Class II	Active
Anti-Sci-70 Antibody Test	K903314	FDA 510(k)	Class II	Active
Anti-Ena Antibody Test (sm)	K920385	FDA 510(k)	Class II	Active
Iga Anti-Gliadin (iga-Aga) Antibody Test Kit	K964341	FDA 510(k)	Class II	Active
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA	K163133	FDA 510(k)	Class II	Active
Thyroid Peroxidase Antibody Elisa	K960369	FDA 510(k)	Class II	Active
Anti-Skin Antibody Test(monkey Esophagus Sections)	K891098	FDA 510(k)	Class II	Active
Igm Rheumatoid Factor	K942272	FDA 510(k)	Class II	Active
ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA	K162788	FDA 510(k)	Class II	Active
Immuglo Anti-Neutrophil Cytoplasmic Antibody (anca) Test Sytem	K982898	FDA 510(k)	Class II	Active
Anti-Cardiolipin Antibody (aca) Screen Elisa	K970177	FDA 510(k)	Class II	Active
Anti-Dsdna Antibody Test	K921658	FDA 510(k)	Class II	Active
Lupus(le)-Latex Test	K905531	FDA 510(k)	Class I	Active
Anti-Cardiolipin Antibody (igm-Aca) Test	K933788	FDA 510(k)	Class II	Active
Thyroglobulin Antibody Elisa	K960370	FDA 510(k)	Class II	Active
Immulisa Sci-70 Antibody Elisa	K113143	FDA 510(k)	Class II	Active
Anti-Rnp And Anti-Sm Antibody Test	K895338	FDA 510(k)	Class II	Active
Immulisa Anca Screen Elisa	K092601	FDA 510(k)	Class II	Active
Immulisa Anti-Beta2 Glycoprotein I (b2gp1) Igm Elisa	K030702	FDA 510(k)	Class II	Active
Immulisa Anti-Human Tissue Transglutaminase (hu-Ttg) Antibody Total Iga/Igg Elisa	K040095	FDA 510(k)	Class II	Active
ImmuLisa Enhanced RNA POL III Antibody ELISA	K172078	FDA 510(k)	Class II	Active
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA	K163177	FDA 510(k)	Class II	Active
Immuglo Anti-Endomysial Antibody Ifa	K060157	FDA 510(k)	Class II	Active
Immulisa Enhanced (tm) Cardiolipin Iga, Igg, Igm And Iga/Igg/Igm Antibody (aca) Elisas	K113020	FDA 510(k)	Class II	Active
Immulisa Pr3 Antibody Elisa	K092600	FDA 510(k)	Class II	Active
Immulisa Anti-Beta2 Glycoprotein I (b2gp1) Igg Elisa	K030701	FDA 510(k)	Class II	Active
Anti-Endomysial Antibody Test	K912551	FDA 510(k)	Class II	Active
Anti-Cardiolipin Antibody (igg-Aca) Test	K933786	FDA 510(k)	Class II	Active
Immulisa Anti-Human Tissue Transglutaminase (hu-Ttg) Antibody Iga Elisa	K032571	FDA 510(k)	Class II	Active
Igg Anti-Gliadin (igg-Aga) Antibody Test Kit	K964344	FDA 510(k)	Class II	Active
Anti-Cardiolipin Antibody (iga-Aca)test)	K933784	FDA 510(k)	Class II	Active
Anti-Skin Antibody Test(monkey/Guin Pig Esoph Sec)	K891099	FDA 510(k)	Class II	Active
Antinuclear Antibody (ana) Test (mouse Liver Sect)	K883949	FDA 510(k)	Class II	Active
Anti-Ss-A (ro) And Anti-Ss-B (la) Antibody Test	K895339	FDA 510(k)	Class II	Active
Immulisa Celiac Ttg Iga And Igg Antibody Elisa	K091520	FDA 510(k)	Class II	Active

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