ABBOTT AXSYM HAVAB 2.0
FDA premarket approval P780012/S009 · decided 2004-02-02
Approval details
- PMA number
- P780012
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT AXSYM HAVAB 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, IL
- Statement
- APPROVAL FOR THE ABBOTT AXSYM HAVAB 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT AXSYM HAVAB 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODY TO HEPATITIS A VIRUS (ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
| ARCHITECT iGentamicin (K243500) | Abbott Laboratories | 2025-07-09 |
| Alinity i Rubella IgG (K243168) | Abbott Laboratories | 2025-06-20 |
| Alinity h-series System (K243283) | Abbott Laboratories | 2025-02-20 |
| Alinity i Toxo IgM (K233932) | Abbott Laboratories | 2024-08-30 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |