ADVIA Centaur Anti-HBe2 (aHBe2) assay

FDA Premarket Approval P200017

Pre-market Approval Supplement Details

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.

DeviceADVIA Centaur Anti-HBe2 (aHBe2) assay
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSiemens Healthcare Diagnostics, Inc.
Date Received2020-03-09
Decision Date2021-07-14
PMAP200017
SupplementS
Product CodeLOM 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue tarrytown, NY 10591-5097

Supplemental Filings

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Supplement NumberDateSupplement Type
P200017Original Filing

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