PMA P790019S016

Device: HAVAB-M EIA
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S016
Product code: LOL
Decision date: 2002-11-06
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: CHANGES TO 1) REPLACE LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM LITTON BIONETICS WITH NON-LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM JACKSON IMMUNO RESEARCH. 2) REPLACE RHEOPHORESIS TESTING FOR GOAT ANTI-HUMAN IGM (ANTIBODY) IDENTITY/SPECIFICITY WITH IMMUNOELECTRO-PHORESIS (IEP) TESTING. 3) REPLACE HAVAB-M RIA (RADIOIMMUNOASSAY) ANTIBODY BEAD COAT EFFICACY TESTING WITH SMALL-SCALE ANTIBODY DILUTION FACTOR DETERMINATION AND CONFIRMATION TESTING USING HAVAB-M EIA (ENZYME IMMUNOASSAY) TO ESTABLISH THE OPTIMAL DILUTION FACTOR OF THE GOAT ANTI-HUMAN IGM ANTIBODY TO BE USED FOR FULL-SCALE PRODUCTION BEAD COATING.

Current openFDA PMA Record#

Device: HAVAB-M EIA
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S016
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2002-11-06
Decision code: OK30
Date received: 2002-10-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO 1) REPLACE LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM LITTON BIONETICS WITH NON-LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM JACKSON IMMUNO RESEARCH. 2) REPLACE RHEOPHORESIS TESTING FOR GOAT ANTI-HUMAN IGM (ANTIBODY) IDENTITY/SPECIFICITY WITH IMMUNOELECTRO-PHORESIS (IEP) TESTING. 3) REPLACE HAVAB-M RIA (RADIOIMMUNOASSAY) ANTIBODY BEAD COAT EFFICACY TESTING WITH SMALL-SCALE ANTIBODY DILUTION FACTOR DETERMINATION AND CONFIRMATION TESTING USING HAVAB-M EIA (ENZYME IMMUNOASSAY) TO ESTABLISH THE OPTIMAL DILUTION FACTOR OF THE GOAT ANTI-HUMAN IGM ANTIBODY TO BE USED FOR FULL-SCALE PRODUCTION BEAD COATING.