Data / Medical devices / Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens (PMT): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens (product code PMT, Class 2, 21 CFR 866.3215). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on February 25, 2020, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- PMT
- Device class
- 2
- Regulation
- 866.3215
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| France | 2 |
| Germany | 2 |
| United Kingdom | 1 |
| Italy | 1 |
| Japan | 1 |
Makers of Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
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 |
|---|---|---|---|---|---|---|---|---|
| Biomerieux SA | MARCY L ETOILE Rhone, France | Manufacturer | 1 | June 28, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | February 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 1 | February 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | June 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Specification developer | 1 | July 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | July 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| B.R.A.H.M.S GmbH | HENNIGSDORF Brandenburg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cezanne SAS | NIMES Gard, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Italia S.p.A. | SALUGGIA Vercelli, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Inc. | Sagamihara-shi Kanagawa, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 25, 2020. 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.