CytoTest Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000054699
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What CytoTest Inc. makes
CytoTest Inc. manufactures DNA in situ hybridization reagents, which are used for detecting and analyzing genetic material within cells. These reagents are designed for laboratory applications in cytogenetic testing, enabling visualization of specific DNA sequences to aid in diagnosing genetic disorders, cancer, and other conditions.
The company’s portfolio falls under the In Vitro Diagnostic (IVD) General category and is registered in the EU’s eudamed database. The products are intended for use within the regulatory frameworks of the European Union, though their specific authorization status varies by device and jurisdiction.
Catalogue
DNA in situ Hybridization Reagents Ref CT-LSPxxx
CE IVDD EUDAMEDDNA in situ Hybridization Reagents Ref CT-PACxxx
CE IVDD EUDAMEDDNA in situ Hybridization Reagents Ref STP-xxx
CE IVDD EUDAMEDDNA in situ Hybridization Reagents Ref CT-CCPxxx
CE IVDD EUDAMED
Company details
- EUDAMED SRN
- US-MF-000054699
- EU VAT number
- 37-1795456
- EUDAMED status
- Active
- EUDAMED registered name
- CytoTest Inc.
- Registered address
- 1395, Piccard Drive, 20850-4349, Rockville, United States
- Website
- www.cytotest.com
- [email protected]
- Phone
- 2026170227
- PRRC contact
- Dr.Reinhard Ebner
FDA establishments
- CytoTest, Inc. Rockville, MD · US FEI 3008849407
Frequently asked questions
How many devices does CytoTest Inc. have in the registry?
The registry currently lists 4 devices for CytoTest Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CytoTest Inc.'s devices?
Among its 4 most recently registered devices, CytoTest Inc. has devices listed in EUDAMED (4 devices).
What risk classes do CytoTest Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for CytoTest Inc.'s devices are IVD general. Each device page shows its own class and authorisation.
What are the newest devices from CytoTest Inc. in the registry?
The most recently registered devices listed for CytoTest Inc. include DNA in situ Hybridization Reagents.
Which FDA establishments are linked to CytoTest Inc.?
1 FDA establishment is linked to CytoTest Inc. in the registry; they are listed on the company page.