• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

1999 Biological Device Application Supplement Approvals

This list reflects information regarding the supplements as of the approval date; it is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.


Tradename Description and Indication for Device Applicant Number Approval Date
Roche Amplicor
HIV-1 RNA Test
An in vitro nucleic acid amplification test used for patient monitoring and as an aid in management of patients on anti-viral therapy for HIV disease Roche Molecular System, Inc
1080 US Highway 202
Branchburg, NJ 08876
BP950005-03 3/2/1999
Ultra-sensitive
AMPLICOR HIV-1 MONITOR Test
Quantitative assay for HIV-1 RNA used to assess a patient's prognosis by measuring changes in plasma HIV-RNA levels during the course of antiviral treatment Roche Molecular System, Inc
1080 US Highway 202
Branchburg, NJ 08876
BP950005-04 3/2/1999