Data / Medical devices / Research Use Only/Clinical Chemistry Devices
Research Use Only/Clinical Chemistry Devices (OTV): 9 FDA-registered makers in 7 countries
9 establishments in 7 countries are registered with the FDA to make Research Use Only/Clinical Chemistry Devices (product code OTV, 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 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OTV
- Device class
- N
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Canada | 2 |
| Denmark | 1 |
| Singapore | 1 |
| Hong Kong | 1 |
| Switzerland | 1 |
| Germany | 1 |
Makers of Research Use Only/Clinical Chemistry 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 |
|---|---|---|---|---|---|---|---|---|
| Agilent Technologies Denmark ApS | GLOSTRUP Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies Singapore (International) Pte Ltd. | Singapore North East, Singapore | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corgenix, Inc. | Broomfield, CO, 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 | |
| Dna Genotek, Inc. | Ottawa Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phase Scientific International Limited | Shatin NT, HONG KONG, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southmedic, Inc. | BARRIE Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Schweiz AG | MAENNEDORF ZUERICH Zurich, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Software Competence Center GmbH | Mainz-Kastel Rhineland-Palatinate, Germany | 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.