ADVIA Centaur Anti-HBe2 (AHBe2) Assay

FDA Premarket Approval P200017 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for migration of the advia centaur anti-hbe2 (ahbe2) assay to the atellica im analyzer. The device, as modified, will be marketed under the trade name atellica im anti-hbe2 (ahbe2).

DeviceADVIA Centaur Anti-HBe2 (AHBe2) Assay
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSiemens Healthcare Diagnostics, Inc.
Date Received2021-08-10
Decision Date2022-01-06
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue tarrytown, NY 10591-5097

Supplemental Filings

Supplement NumberDateSupplement Type
P200017Original Filing
S001 2021-08-10 Normal 180 Day Track

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