| 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 | ADVIA Centaur Anti-HBe2 (aHBe2) assay |
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| Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | Siemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
Tarrytown, NY 10591-5097 |
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| PMA Number | P200017 |
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| Date Received | 03/09/2020 |
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| Decision Date | 07/14/2021 |
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| Product Code |
LOM |
| 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 of the ADIVA Centaur Anti-HBe2 (aHBe2) assay. The qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2–21 years old) and adult serum, EDTA plasma, or lithium heparin plasma using the ADVIA Centaur systems (XP/XPT/CP). Assay results, in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis B virus (HBV) infection in patients with signs or symptoms of hepatitis B infection, or with risk factors for HBV infection, or with known HBV infection. Results of the assay, in conjunction with other diagnostic information, may be used to aid in determining HBV seroconversion. |
| 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: |
S001 S002 |
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