ABBOTT HAVAB/HAVAB EIA/IMX HAVAB
FDA premarket approval P780012/S011 · decided 2002-09-05
Approval details
- PMA number
- P780012
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT HAVAB/HAVAB EIA/IMX HAVAB
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 2001-10-03
- Decision date
- 2002-09-05
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO ADD TESTING OF A SENSITIVITY PANEL FOR QUALIFICATION OF THE HEPATITIS A VIRUS EXTRACT USED IN THE HAVAB ASSAYS TO COAT THE SOLID PHASE OF THE BEAD AND TO TIGHTEN ASSAY ACCEPTANCE SPECIFICATION FOR HAV ANTIGEN QUALIFICATION.
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 |