PMA P780012S011

Device: ABBOTT HAVAB/HAVAB EIA/IMX HAVAB
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S011
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 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.

Current openFDA PMA Record#

Device: ABBOTT HAVAB/HAVAB EIA/IMX HAVAB
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S011
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 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.