HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
FDA premarket approval P980046 · decided 1999-04-28
Approval details
- PMA number
- P980046
- Trade name
- HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
- Generic name
- Immunoassay for the detection of antibody to Hepatitis C Virus intended for over the counter use
- Applicant
- Pwn Health Chicago, LLC
- Date received
- 1998-12-07
- Decision date
- 1999-04-28
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- QRO
- Advisory committee
- Microbiology
- Expedited review
- Yes
- Location
- New York, NY
- Statement
- Approval for the Home Access(R) Hepatitis C Check(SM) and Hepatitis C Check(SM) Express. This device is indicated for home use for collection of a dried blood spot speciment by finger-stick, and is indicated for anonymous testing for antibody to hepatitis C virus (HCV) in adults, eighteen years or older, who may have been exposed to HCV through transfusion or organ transplant before 1992, who may have injected non-prescription durgs, or who were exposed to infected needles or had sexual contacts
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