HAVAB-M EIA
FDA premarket approval P790019/S016 · decided 2002-11-06
Approval details
- PMA number
- P790019
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HAVAB-M EIA
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 2002-10-07
- Decision date
- 2002-11-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park North, IL
- 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 E
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