ABBOTT HAVAB/HAVAB EIA/IMX HAVAB
FDA premarket approval P780012/S012 · decided 2002-09-05
Approval details
- PMA number
- P780012
- Supplement
- S012
- Supplement type
- 30-Day Notice
- 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
- 2001-10-04
- Decision date
- 2002-09-05
- Days to decision
- 336 days
- Decision code
- OK30
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- ADDITION OF A MANUFACTURERS WORKING CELL BANK (MWCB) AND LIMITING THE NUMBER OF CELL PASSAGES THAT CAN BE PERFORMED FOR ANTIGEN PRODUCTION USING CELLS FROM THE NEW MWCB.
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