DIASORIN ETI-HA-IGMK PLUS
FDA premarket approval P890014/S002 · decided 1998-09-16
Approval details
- PMA number
- P890014
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIASORIN ETI-HA-IGMK PLUS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- DiaSorin, Inc.
- Date received
- 1997-11-24
- Decision date
- 1998-09-16
- Days to decision
- 296 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 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 E
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510(k) clearances by this applicant
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