QIAGEN Manchester, Ltd.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What QIAGEN Manchester, Ltd. makes
QIAGEN Manchester, Ltd. manufactures the Therascreen KRAS RGQ PCR Kit, a diagnostic tool designed for detecting KRAS gene mutations in tissue or plasma samples using real-time polymerase chain reaction (PCR) technology. This device supports precision oncology by identifying specific mutations linked to cancer treatment response and resistance, particularly in colorectal and non-small cell lung cancers.
The Therascreen KRAS RGQ PCR Kit is classified as a Class III medical device under FDA regulations and is authorised via a Premarket Approval (PMA) application. The company is based in the United States and its products are listed in the FDA’s regulatory database.
Catalogue
Therascreen Kras Rgq Pcr Kit Ref P110030
PMA, withdrawn PMA
FDA establishments
- QIAGEN Manchester Ltd Manchester Lancashire · GB FEI 3009391812
Frequently asked questions
How many devices does QIAGEN Manchester, Ltd. have in the registry?
The registry currently lists 1 device for QIAGEN Manchester, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list QIAGEN Manchester, Ltd.'s devices?
Among its 1 most recently registered device, QIAGEN Manchester, Ltd. has devices listed in FDA PMA (1 device).
What risk classes do QIAGEN Manchester, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for QIAGEN Manchester, Ltd.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from QIAGEN Manchester, Ltd. in the registry?
The most recently registered devices listed for QIAGEN Manchester, Ltd. include THERASCREEN KRAS RGQ PCR KIT.
Which FDA establishments are linked to QIAGEN Manchester, Ltd.?
1 FDA establishment is linked to QIAGEN Manchester, Ltd. in the registry; they are listed on the company page.