PMA P890014S002

Device: DIASORIN ETI-HA-IGMK PLUS
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S002
Product code: LOL
Decision date: 1998-09-16
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: Approval for a change in the Enzyme tracer and Tracer Diluent from a IgG (sheep) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a chang ein the Positive Control material to a human source sera; the elimination of the mercury preservative in the reagents; a change in the incubation times from an overnight procedure to a four and one-half hour incubation; the addition of an indicator dye; and the addition of a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-HA-IGMK PLUS and is intended for use in the qualitative determination of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the diagnosis and monitoring of acute or recent hepatitis A virus infection.

Current openFDA PMA Record

Device: DIASORIN ETI-HA-IGMK PLUS
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S002
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 1998-09-16
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 a IgG (sheep) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a chang ein the Positive Control material to a human source sera; the elimination of the mercury preservative in the reagents; a change in the incubation times from an overnight procedure to a four and one-half hour incubation; the addition of an indicator dye; and the addition of a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-HA-IGMK PLUS and is intended for use in the qualitative determination of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the diagnosis and monitoring of acute or recent hepatitis A virus infection.