|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||HEPATITIS C CHECK TESTING SERVICE|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Applicant||HOME ACCESS HEALTH CORP.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
As a final packaging option, the outer packaging of the hepatitis c check product may be assembled in a softpak package or the currently approved paperboard packaging when shipped directly to clients.