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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantHOME ACCESS HEALTH CORP.
PMA NumberP980046
Date Received12/07/1998
Decision Date04/28/1999
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 99M-2143
Notice Date 07/13/1999
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S002 S004 S005 S006 S007 S008 
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