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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2000 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
Home Access HIV-1 Test System HIV Testing Service to be used with the Organon Teknika Vironostika HIV-1 Microelisa System Home Access Health Corp
2401 West Hassell Rd
Suite 1510
Hoffman Estates, IL 60195-5200
BP950002-02 3/15/2000
Roche Amplicor HIV-1 Monitor Test In vitro test for the quantitation of HIV-1 RNA in human plasma Roche Molecular System, Inc
4300 Hacienda Dr
P.O. Box 9002
Pleasanton, CA 94566-0990
BP950005-01 4/10/2000