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Sign in to claim this brandImmco 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
- —
- —
- [email protected]
- Phone
- +17166910091
- PRRC Contact
- Lee Kroening
- EUDAMED SRN
- US-MF-000035173
- FDA FEI Number
- 3015376545
- DUNS Number
- —
Catalogue (243)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Immco Diagnostics | 1102-120X | FDA UDI | Class II | Active |
| Immco Diagnostics | 2107X | FDA UDI | Class II | Active |
| Immco Diagnostics | 1107 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1106X | FDA UDI | Class II | Active |
| Immco Diagnostics | 1119 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1152G | FDA UDI | Class II | Unknown |
| Immco Diagnostics | 5138M | FDA UDI | Class II | Active |
| Immco Diagnostics | 2514 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1134X | FDA UDI | Class II | Active |
| Immco Diagnostic | 2107 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1114G-PDE | FDA UDI | Class II | Active |
| Immco Diagnostics | 2500LONG | FDA UDI | Class II | Active |
| Immco Diagnostics | 2215 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1114A-PDE-250 | FDA UDI | Class II | Active |
| Immco Diagnostics | 2113-15 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1140 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1103-210 | FDA UDI | Class II | Unknown |
| Immco Diagnostics | 1103-525X | FDA UDI | Class II | Active |
| Immco Diagnostics | 2155-8 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1106 | FDA UDI | Class II | Active |
| Immco Diagnostics | 2205 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1102-120 | FDA UDI | Class II | Active |
| Immco Diagnostics, Inc | 5152A | FDA UDI | Class II | Unknown |
| Immco Diagnostics | 2500 | FDA UDI | Class II | Active |
| Immco Diagnostics | 2310 | FDA UDI | Class II | Active |
| Immco Diagnostics | 5308 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1114-96 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1103X | FDA UDI | Class II | Active |
| Immco Diagnostics | 2314 | FDA UDI | Class II | Active |
| Immco Diagnostics | 2201 | FDA UDI | Class II | Active |
| Immco Diagnostics | 5118S | FDA UDI | Class II | Unknown |
| Immco Diagnostics, Inc | 1108 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1103-480 | FDA UDI | Class II | Unknown |
| Immco Diagnostics | 1136-250X | FDA UDI | Class II | Active |
| Immco Diagnostics | 2202 | FDA UDI | Class II | Active |
| Immco Diagnostics | 1140X | FDA UDI | Class II | Active |
| Immco Diagnostics | 2240 | FDA UDI | Class II | Active |
| Immco DIagnostics, Inc. | 5152S | FDA UDI | Class II | Unknown |
| Immulisa Anti-Saccharomyces Cerevisiae Antibody (asca) (igg) | K032850 | FDA 510(k) | Class II | Active |
| Anti-Reticulin Antibody (ara) Test | K913360 | FDA 510(k) | Class II | Active |
| Autoantibody Test System (mouse Kidney/Stomach) | K883915 | FDA 510(k) | Class II | Active |
| Anti-Tissue Transglutaminase (ttg)antibody Test | K992878 | FDA 510(k) | Class II | Active |
| Immulisa Anti-Saccharomyces Cerevisiae Antibody (asca) (iga) | K032860 | FDA 510(k) | Class II | Active |
| Immulisa Antinuclear Antibody Screen Elisa | K041102 | FDA 510(k) | Class II | Active |
| ImmuLisa Enhanced Centromere Antibody ELISA | K151559 | FDA 510(k) | Class II | Active |
| Anti-Native Dna Antibody Test (crithidia Luciliae) | K884400 | FDA 510(k) | Class II | Active |
| Anti-Histone Anibody Test | K943585 | FDA 510(k) | Class II | Active |
| ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | K143736 | FDA 510(k) | Class II | Active |
| Anti-Ena Antibody Test [ss-A (ro)] | K920383 | FDA 510(k) | Class II | Active |
| Anti-Ena Antibody Test Kit | K920386 | FDA 510(k) | Class II | Active |
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