Data / Medical devices / Switzerland / Preanalytix GMBH
Preanalytix GMBH: FDA-registered device maker in HOMBRECHTIKON Zurich, Switzerland, 2 510(k) clearances
Preanalytix GMBH is registered with the FDA (registration 3005202328) in HOMBRECHTIKON Zurich, Switzerland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005202328
- Address
- Garstligweg 8, HOMBRECHTIKON Zurich, Switzerland, CH-8634
- Owner or operator
- PreAnalytiX GMBH (9073981)
- Roles
- Specification developer
- First device listed
- July 10, 2023
- Registered through
- 2026
- Brand names listed
- PAXgene(R) Blood DNA Tube, PAXgene® Blood RNA System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood/Plasma Collection Device For Dna Testing | PJE | 2 | Specification developer | accessdata.fda.gov |
| System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test | NTW | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 21, 2023 | K231469 | PAXgene® Blood DNA Tube | PJE | Substantially Equivalent | Preanalytix GmbH | accessdata.fda.gov |
| February 4, 2009 | K082150 | MODIFICATION TO PAXGENE BLOOD RNA SYSTEM | NTW | Substantially Equivalent | Preanalytix GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
- All makers of Blood/Plasma Collection Device For Dna Testing
Updated June 21, 2023. 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.