DIASORIN ETI-AB-COREK PLUS ASSAY
FDA premarket approval P990045 · decided 2001-03-30
Approval details
- PMA number
- P990045
- Trade name
- DIASORIN ETI-AB-COREK 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-COREK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-AB-COREK PLUS IS IAN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-AB-COREK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR
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