Immco Diagnostics, Inc.
Active in EUDAMEDUnited Statesfrom EUDAMED address EUDAMED FDA SRN US-MF-000035173 FEI 3015376545
Immco Diagnostics, Inc. is a medical device manufacturer based in the United States, with 243 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.
- Devices
- 243
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 188
- FDA 510(k) 55
- Device classes
- FDA Class II 239
- FDA Class I 1
- Identifiers
- EUDAMED SRN US-MF-000035173
- FDA FEI 3015376545
- DUNS 079935300
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Immco Diagnostics, Inc. makes
Immco Diagnostics, Inc. manufactures in vitro diagnostic (IVD) kits and reagents for autoimmune disease testing, including multiple antinuclear antibody (ANA) screening, endomysium antibody (EMA), anti-neutrophil cytoplasmic antibody (ANCA), skin antibody, and native DNA antibody tests, as well as general specimen microscopy slides and clinical chemistry protein immunoblot kits.
The company's products are regulated as Class I and Class II devices and are listed in the FDA 510(k) and FDA UDI registries. Immco Diagnostics is based in the US.
Catalogue
Search and filter all 243 devicesShowing 1-50 of 243
Company details
- EUDAMED SRN
- US-MF-000035173
- FDA FEI number
- 3015376545
- DUNS number
- 079935300
- EUDAMED status
- Active
- EUDAMED registered name
- Immco Diagnostics, Inc.
- Address
- 10 Earhart Drive, Williamsville, NY, 14221
- Website
- www.trinitybiotech.com
- info@immco.com
- Phone
- +17166910091
- PRRC contact
- Lee Kroening
From the company website
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.
Frequently asked questions
How many devices does Immco Diagnostics, Inc. have in the registry?
The registry currently lists 243 devices for Immco Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immco Diagnostics, Inc.'s devices?
Among its 50 most recently registered devices, Immco Diagnostics, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Immco Diagnostics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Immco Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immco Diagnostics, Inc. in the registry?
The most recently registered devices listed for Immco Diagnostics, Inc. include Immco Diagnostics, Inc. 5117A, IMMCO DIAGNOSTICS 5162, Immco Diagnostics, Inc. 6101M-50 and Immco Diagnostics, Inc. 5163S.