|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||APTIMA HPV 16 18/45 GENETYPE ASSAY|
|Classification Name||kit, rna detection, human papillomavirus|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the minor software changes for the aptima hpv assay software (v2. 3. 5), the aptima hpv-gt assay software (v2. 7. 5), panther system software (v5. 2).