Vaccines, Blood & Biologics
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Home Access HIV-1 Test System
Product: Home Access HIV-1 Test System
Applicant: Home Access Health Corp
PMA number: BP950002
Indication for use: For self-use by people who wish to obtain anonymous HIV testing.
Approval Date: 7/22/96
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Supporting Documents
Summary - Home Access HIV-1 Test System (PDF - 1.3MB)Letter - Home Access HIV-1 Test System
Approval Date: 7/22/96
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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