Data / Medical devices / Research Use Only/Immunology Devices
Research Use Only/Immunology Devices (OTR): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Research Use Only/Immunology Devices (product code OTR, Class N). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OTR
- Device class
- N
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 2 |
| Italy | 1 |
| Singapore | 1 |
Makers of Research Use Only/Immunology Devices
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnostica Stago, Inc. | Parsippany, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Deutschland GmbH | Dietzenbach Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Italia S.p.A. | SALUGGIA Vercelli, Italy | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ibl International GMBH | Hamburg, Germany | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MP Biomedicals Asia Pacific Pte Ltd | Singapore Central Singapore, Singapore | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sun Diagnostics, LLC | New Gloucester, ME, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.