Qiagen Gaithersburg, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Qiagen Gaithersburg, Inc. makes
Qiagen Gaithersburg, Inc. manufactures the Digene Hybrid Capture 2 (HC2) HPV DNA test, a diagnostic assay designed to detect high-risk human papillomavirus DNA in clinical specimens. The product is a molecular diagnostic test used for cervical cancer screening and related applications.
The HC2 HPV DNA test is classified as a Class III medical device and is listed under the FDA's Premarket Approval (PMA) pathway. Qiagen Gaithersburg, Inc. is based in the United States.
Catalogue
Digene Hybrid Capture 2 (HC2) Hpv Dan Test Ref P890064
PMA PMA
FDA recalls
FDA recall records list 3 recalls initiated by Qiagen Gaithersburg, Inc., the earliest on 2011-01-12 and the most recent on 2013-01-30. By recorded status: 3 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 30 Jan 2013 Z-1320-2013 Class II Terminated CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
- 30 Jan 2013 Z-1321-2013 Class II Terminated CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
2011
- 12 Jan 2011 Z-1728-2011 Unclassified (pre-2012) Terminated The software component of a diagnostic medical device may be defective and could cause incorrect patient values.
Frequently asked questions
How many devices does Qiagen Gaithersburg, Inc. have in the registry?
The registry currently lists 1 device for Qiagen Gaithersburg, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qiagen Gaithersburg, Inc.'s devices?
Among its 1 most recently registered device, Qiagen Gaithersburg, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Qiagen Gaithersburg, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Qiagen Gaithersburg, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Qiagen Gaithersburg, Inc.?
FDA recall records list 3 recalls initiated by Qiagen Gaithersburg, Inc., the most recent initiated on 2013-01-30. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Qiagen Gaithersburg, Inc. in the registry?
The most recently registered devices listed for Qiagen Gaithersburg, Inc. include DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST.