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Sign in to claim this brandDiaSys Diagnostic Systems GmbH
US
Last updated May 23, 2026
Information
- Country
- US
- Address
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- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- 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 |
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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