Data / Medical devices / Germany / Diasys Diagnostic Systems GMBH
Diasys Diagnostic Systems GMBH: FDA-registered device maker in Holzheim Rhineland-Palatinate, Germany, 1 510(k) clearance
Diasys Diagnostic Systems GMBH is registered with the FDA (registration 3006644620) in Holzheim Rhineland-Palatinate, Germany. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006644620
- Address
- Alte Strasse 9, Holzheim Rhineland-Palatinate, Germany, D-65558
- Owner or operator
- DIASYS DIAGNOSTIC SYSTEMS GMBH (9105042)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 7, 2007
- Registered through
- 2026
- Brand names listed
- ?-Hydroxybutyrate 21 Bi-Level Controls, ?-Hydroxybutyrate 21 FS, ?-Hydroxybutyrate 21 Linearity Standards, ?-Hydroxybutyrate 21 Tri-Level Controls, Atellica CH Bilirubin Calibrator, Atellica CH Triglycerides_2, DiaSys Procalcitonin FS Assay, DiaSys TruCaI Procalcitonin Calibrator Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission | PTF | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 9, 2025 | K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls | PTF | Substantially Equivalent | Diasys Diagnostic Systems GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- All makers of Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Updated May 9, 2025. 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.