Preanalytix GmbH
Country not established FDA
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Preanalytix GmbH makes
Preanalytix GmbH manufactures evacuated blood collection tubes and nucleic acid extraction/isolation kits designed for in vitro diagnostic (IVD) use. These products include blood tubes with anticoagulants and nucleic acid stabilizers, as well as kits for isolating DNA and RNA from blood samples. The portfolio includes systems for preserving and extracting genetic material for downstream molecular testing.
The company’s devices are classified as Class II under FDA regulations and are authorised via 510(k) premarket notifications and the Unique Device Identifier (UDI) system. These products are listed in the FDA’s regulatory databases, reflecting their compliance with U.S. medical device requirements. The manufacturer is based in the United States.
Catalogue
- Regimes: CE IVDR Registry: EUDAMEDGUDID
- Regimes: CE IVDR Registry: GUDID
- Regimes: CE IVDR Registry: EUDAMEDGUDID
PAXgene Blood DNA Tube Ref K142821
Regimes: CE IVDR 510(k) Registry: 510(k)Paxgene Blood Rna System Ref DEN050003
Regimes: De Novo Registry: De NovoPAXgene® Blood DNA Tube Ref K231469
Regimes: 510(k) Registry: 510(k)Modification To Paxgene Blood Rna System Ref K082150
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 480915029
FDA establishments
- Preanalytix GmbH HOMBRECHTIKON Zurich · CH FEI 3005202328
Frequently asked questions
How many devices does Preanalytix GmbH have in the registry?
The registry currently lists 7 devices for Preanalytix GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Preanalytix GmbH's devices?
Among its 7 most recently registered devices, Preanalytix GmbH has devices listed in EUDAMED (2 devices), FDA 510(k) (4 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Preanalytix GmbH's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Preanalytix GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Preanalytix GmbH in the registry?
The most recently registered devices listed for Preanalytix GmbH include PAXgene® Blood DNA Tube 761165, PAXgene® Blood RNA Kit Version 2, PAXgene® Blood RNA Tube 762165 and PAXgene Blood DNA Tube.
Which FDA establishments are linked to Preanalytix GmbH?
1 FDA establishment is linked to Preanalytix GmbH in the registry; they are listed on the company page.