Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDiaSys Diagnostic Systems GmbH
US
Last updated May 23, 2026
What DiaSys Diagnostic Systems GmbH makes
DiaSys Diagnostic Systems GmbH manufactures in vitro diagnostic (IVD) products for beta-hydroxybutyrate and procalcitonin (PCT) testing, including controls, calibrators, reagents, and linearity standards. Their beta-hydroxybutyrate portfolio includes spectrophotometry-based kits and controls, while their PCT offerings cover calibrators, controls, and reagents designed for laboratory use. Examples include β-Hydroxybutyrate 21 FS, TruLab Procalcitonin Bi-Level Controls, and TruCal Procalcitonin Calibrator Set.
The company’s products are regulated under FDA pathways, including 510(k) clearances and Unique Device Identification (UDI) listings. Devices fall into Class I and Class II classifications, depending on their risk level and intended use. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does DiaSys Diagnostic Systems GmbH manufacture?
DiaSys Diagnostic Systems GmbH specializes in in vitro diagnostic (IVD) products focused on beta-hydroxybutyrate and procalcitonin (PCT) testing. Their portfolio includes controls (like β-Hydroxybutyrate 21 Tri-Level Controls), calibrators (such as TruCal Procalcitonin Calibrator Set), spectrophotometry-based kits for beta-hydroxybutyrate, and reagents (e.g., DiaSys Procalcitonin FS). These products are designed to support laboratory diagnostics for monitoring metabolic markers and infection biomarkers.
Where is DiaSys Diagnostic Systems GmbH based?
DiaSys Diagnostic Systems GmbH is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary. This location aligns with regulatory pathways like FDA clearance and UDI compliance for their IVD devices.
Which regulatory registries or databases list DiaSys Diagnostic Systems GmbH’s devices?
DiaSys Diagnostic Systems GmbH’s devices are listed in the FDA’s 510(k) clearance registry and the Unique Device Identification (UDI) database. These registries track devices that have undergone FDA review and received clearance under applicable pathways. Listing in these databases ensures traceability and compliance with U.S. regulatory requirements for IVD products.
How are DiaSys Diagnostic Systems GmbH’s devices classified under FDA regulations?
DiaSys Diagnostic Systems GmbH’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the level of regulatory oversight needed for its specific diagnostic purpose.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 328419718
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| β-Hydroxybutyrate 21 FS | 137119943018 | FDA UDI | Class I | Active |
| β-Hydroxybutyrate 21 Tri-Level Controls | 595709943085 | FDA UDI | Class I | Active |
| DiaSys Procalcitonin FS | 173189943018 | FDA UDI | Class II | Active |
| β-Hydroxybutyrate 21 Bi-Level Controls | 595409943084 | FDA UDI | Class I | Active |
| TruLab Procalcitonin Bi-Level Controls | 599809943086 | FDA UDI | Class I | Active |
| TruCal Procalcitonin Calibrator Set | 173109943082 | FDA UDI | Class I | Active |
| β-Hydroxybutyrate 21 Linearity Standards | 137209943052 | FDA UDI | Class II | Active |
| β-Hydroxybutyrate 21 FS | 137119943019 | FDA UDI | Class I | Active |
| Aspartate Amino Transferase (ast/Sgot) Test System, Asat (got) Fs | K080485 | FDA 510(k) | Class II | Active |
| DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls | K242294 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Diasys Diagnostic Systems Gmbh Holzheim Rhineland-Palatinate · DE FEI 3006644620