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.
| Device | HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | HOME ACCESS HEALTH CORP. |
| Date Received | 1998-12-07 |
| Decision Date | 1999-04-28 |
| Notice Date | 1999-07-13 |
| PMA | P980046 |
| Supplement | S |
| Product Code | MZO |
| Docket Number | 99M-2143 |
| Advisory Committee | Microbiology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | HOME ACCESS HEALTH CORP. 2401 W. Hassell suite 1510 hoffman Estates, IL 60195-5200 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980046 | | Original Filing |
| S009 |
2015-09-22 |
Normal 180 Day Track |
| S008 |
2011-08-01 |
30-day Notice |
| S007 |
2004-12-03 |
30-day Notice |
| S006 |
2003-05-28 |
Normal 180 Day Track No User Fee |
| S005 |
2002-10-24 |
Normal 180 Day Track |
| S004 |
2001-02-23 |
Normal 180 Day Track |
| S003 | | |
| S002 |
2000-03-23 |
30-day Notice |
| S001 | | |
NIH GUDID Devices