This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Change of a suppliers manufacturing site for a critical component.
|Generic Name||Kit, Dna Detection, Human Papillomavirus|
|Applicant||Roche Molecular Systems, Inc.|
|Supplement Type||30-day Notice|
|Supplement Reason||Process Change - Manufacturer/sterilizer/packager/supplier|
|Applicant Address||Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588|
|Supplement Number||Date||Supplement Type|