Data / Medical devices / Austria / Technoclone
Technoclone: FDA-registered device maker in Vienna Wien, Austria, 1 510(k) clearance
Technoclone is registered with the FDA (registration 3003453957) in Vienna Wien, Austria. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 28, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003453957
- Address
- Brunner Strase 67, Vienna Wien, Austria, 1230
- Owner or operator
- Technoclone Herstellung v. Diagnostika u. Arzneimitteln GmbH (10031758)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 5, 2010
- Registered through
- 2026
- Brand names listed
- DG Clean, Technozym ADAMTS13 Activity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adamts13 Activity Test System | SAC | 2 | Manufacturer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Contract manufacturer | accessdata.fda.gov |
| Calibrator, Primary | JIS | 2 | Contract manufacturer | accessdata.fda.gov |
| Detergent | JCB | 1 | Contract manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| February 28, 2024 | DEN230024 | Technozym ADAMTS13 Activity | SAC | Unknown | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM | accessdata.fda.gov |
Compare with other makers
- All makers of Detergent
- All makers of Plasma, Coagulation Control
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Calibrator, Primary
Updated February 28, 2024. 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.