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Device | 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 | PWNHealth Chicago LLC 123 W 18th Street New York, NY 10002 |
PMA Number | P980046 |
Date Received | 12/07/1998 |
Decision Date | 04/28/1999 |
Product Code |
QRO |
Docket Number | 99M-2143 |
Notice Date | 07/13/1999 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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 with HCV infected individuals. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S002 S004 S005 S006 S007 S008 S009 |