DIASORIN ETI-AB-AUK PLUS ASSAY
FDA premarket approval P990042 · decided 2001-03-30
Approval details
- PMA number
- P990042
- Trade name
- DIASORIN ETI-AB-AUK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- Date received
- 1999-07-02
- Decision date
- 2001-03-30
- Days to decision
- 637 days
- Decision code
- APWD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR THE DIASORIN ETI-AB-AUK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-AB-AUK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-AB-AUK PLUS IS INTENDED FOR MANUAL USE ONLY. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS FOR SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. ANTI-HBS IS ALSO USED TO ASSESS LABORATORY
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