Data / Medical devices / Procalcitonin Assay
Procalcitonin Assay (PRI): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Procalcitonin Assay (product code PRI, Class 2, 21 CFR 866.3215). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on August 26, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PRI
- Device class
- 2
- Regulation
- 866.3215
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 2 |
| France | 2 |
| Italy | 1 |
| Japan | 1 |
Makers of Procalcitonin Assay
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 |
|---|---|---|---|---|---|---|---|---|
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 2 | March 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| B.R.A.H.M.S GmbH | HENNIGSDORF Brandenburg, Germany | Specification developer | 1 | May 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux SA | MARCY L ETOILE Rhone, France | Manufacturer | 1 | February 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| DiaSorin Italia S.p.A. | SALUGGIA Vercelli, Italy | Manufacturer | 1 | February 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | June 1, 2017 | 0 | 0 | 0 | api.fda.gov |
| Fujirebio Inc. | Sagamihara-shi Kanagawa, Japan | Manufacturer | 1 | December 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | August 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cezanne SAS | NIMES Gard, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 26, 2022. 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.