Hepatitis A Test (Antibody And Igm Antibody)
Basic Information
- Device Name
- Hepatitis A Test (Antibody And Igm Antibody)
- Trade Name
- AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS
- PMA Number
- P890019
- Supplement Number
- S005
- Device Class
- FDA Class 2
- Product Code
- LOL
- Generic Name
- Hepatitis a test (antibody and igm antibody)
- Regulation Number
- 866.3310
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 22, 1998
- Date Received
- November 24, 1997
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | FDA class 2 | Microbiology |