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Device | DIASORIN ETI-AB-EBK PLUS ASSAY |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. STILLWATER, MN 55082-0285 |
PMA Number | P990041 |
Date Received | 07/02/1999 |
Decision Date | 03/30/2001 |
Withdrawal Date
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10/10/2023 |
Docket Number | 01M-0452 |
Notice Date | 10/09/2001 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DIASORIN ETI-AB-EBK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-AB-EBK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-AB-EBK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE DETECTION OF ANTI-HBE IS INDICATIVE OF LABORATORY DIAGNOSIS FOR SEROCONVERSION AND PROGRESSION TO HEPATITIS B VIRUS (HBV) CLEARANCE. A REACTIVE TEST IS PRESUMPTIVE LABORATORY EVIDENCE OF HBV SEROCONVERSION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ANTI-HBE ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 S013 S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 S026 S027 S028 S029 S030 S031 |