PMA P890019S005

Device: AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS
Applicant: Diasorin
PMA number: P890019
Supplement: S005
Product code: LOL
Decision date: 1998-09-22
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: Approval for a change in the Enzyme tracer and Tracer Diluent from an IgG (Human) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a change in the Positive Control and Negative Control materials to human source sera; the elimination of the mercury preservative in the reagents; and the addition of a neutralizing solution, incubation buffer and a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-AB-HAVK PLUS and is intended for the qualitative determination of total antiboides to hepatitis A virus (anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the dignosis of current or previous hepatitis A virus infection and as an aid in the diagnosis of current or previous hepatitis A virus infection and as an aid in the identification of HAV-susceptible individuals for vaccination.

Current openFDA PMA Record

Device: AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS
Applicant: Diasorin
PMA number: P890019
Supplement: S005
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 1998-09-22
Decision code: APPR
Date received: 1997-11-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change in the Enzyme tracer and Tracer Diluent from an IgG (Human) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a change in the Positive Control and Negative Control materials to human source sera; the elimination of the mercury preservative in the reagents; and the addition of a neutralizing solution, incubation buffer and a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-AB-HAVK PLUS and is intended for the qualitative determination of total antiboides to hepatitis A virus (anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the dignosis of current or previous hepatitis A virus infection and as an aid in the diagnosis of current or previous hepatitis A virus infection and as an aid in the identification of HAV-susceptible individuals for vaccination.