Premarket Approval Information - Devices

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


Summary (PDF - 1.2 MB)

Label (PDF - 2.2 MB)

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Updated: March 1, 2001