| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | DIASORIN ETI-EBK PLUS ASSAY |
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| Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | DIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285 |
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| PMA Number | P990043 |
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| Date Received | 07/02/1999 |
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| Decision Date | 02/08/2001 |
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Withdrawal Date
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10/10/2023 |
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| Product Code |
LOM |
| Docket Number | 01M-0454 |
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| Notice Date | 10/09/2001 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE DIASORIN ETI-EBK PLUS ASSAY. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF HEPATITIS BE ANTIGEN (HBEAG) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-EBK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE DETECTION OF HBEAG IS INDICATIVE OF ACTIVE HBV REPLICATION, USUALLY CORRELATING WITH VIREMIA. A REACTIVE TEST IS PRESUMPTIVE LABORATORY EVIDENCE FOR INFECTION WITH HEPATITIS B VIRUS (HBV). FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE HBEAG ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 S013
S014 S015 S017 S018 S019 S020 S021 S022 S023 S024 S025 S027
S028 S029 S030 S031 S032 |
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