PMA P210019S004

Device: Atellica IM HBc Total 2 (HBcT2)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P210019
Supplement: S004
Product code: LOM
Decision date: 2025-10-17
Classification: Microbiology
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval for the Atellica CI Analyzer with Atellica Sample Handler configuration for Atellica IM HBcT2, aHBs2, HBeAg, aHBcM, aHBe2, HBsII & HBsII Conf assays.

Current openFDA PMA Record#

Device: Atellica IM HBc Total 2 (HBcT2)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P210019
Supplement: S004
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2025-10-17
Decision code: APPR
Date received: 2025-08-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Atellica CI Analyzer with Atellica Sample Handler configuration for Atellica IM HBcT2, aHBs2, HBeAg, aHBcM, aHBe2, HBsII & HBsII Conf assays.