AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS
FDA premarket approval P890019/S005 · decided 1998-09-22
Approval details
- PMA number
- P890019
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Diasorin
- Date received
- 1997-11-24
- Decision date
- 1998-09-22
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- 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 o
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS (K130321) | Diasorin | 2013-04-09 |