PMA P780012S010

Device: HAVAB (R) EIA
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S010
Product code: LOL
Decision date: 2002-09-05
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: APPROVAL TO ADD TESTING OF A SENSITIVITY PANEL TO THE DILUTION FACTOR CONFIRMATION PERFORMED IN THE TESTING OF THE HAVAB CONJUGATE AND TO ADD ADDITIONAL TESTING OF THE HAVAB EIA MASTERLOT TO PROVIDE A QUALITY CHECK OF THE FINAL PACKAGED KIT.

Current openFDA PMA Record#

Device: HAVAB (R) EIA
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S010
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2002-09-05
Decision code: APPR
Date received: 2001-10-03
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO ADD TESTING OF A SENSITIVITY PANEL TO THE DILUTION FACTOR CONFIRMATION PERFORMED IN THE TESTING OF THE HAVAB CONJUGATE AND TO ADD ADDITIONAL TESTING OF THE HAVAB EIA MASTERLOT TO PROVIDE A QUALITY CHECK OF THE FINAL PACKAGED KIT.