ABBOTT AXSYM HAVAB-M 2.0
FDA premarket approval P790019/S011 · decided 2004-02-02
Approval details
- PMA number
- P790019
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT AXSYM HAVAB-M 2.0
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 2000-06-09
- Decision date
- 2004-02-02
- Days to decision
- 1333 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park North, IL
- Statement
- APPROVAL FOR THE ABBOTT AXSYM HAVAB-M 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AXSYM HAVAB-M 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION IF IGM ANTIBODY TO HEPATITIS A VIRUS (IGM ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR IGM ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS A VIRAL INFECTION.
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