PMA P200017S001

Device: ADVIA Centaur Anti-HBe2 (AHBe2) Assay
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P200017
Supplement: S001
Product code: LOM
Decision date: 2022-01-06
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: 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).

Current openFDA PMA Record#

Device: ADVIA Centaur Anti-HBe2 (AHBe2) Assay
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P200017
Supplement: S001
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2022-01-06
Decision code: APPR
Date received: 2021-08-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: 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).