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Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA product code SEI · Class 2 · Microbiology
32
Registered devices
4
Adverse events
0
Recalls
4
510(k) clearances
Devices with this code
IMMULITE® 2000 Systems BcM Anti-HBc IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® Systems aHBs2 QC — Siemens Healthcare Diagnostics Inc.Atellica IM HBcT2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAccess anti-HBc IgM — Beckman Coulter, Inc.Atellica™ IM aHBcM — Siemens Healthcare Diagnostics Inc.Atellica IM HBcT — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® aHBs2 — Siemens Healthcare Diagnostics Inc.Atellica™ IM HBcT QC — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® HBcT — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® HBcT2 Quality Control Kit — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAtellica IM aHBcM — Siemens Healthcare Diagnostics Inc.Atellica™ IM HBcT — Siemens Healthcare Diagnostics Inc.Atellica IM HBcT2 QC — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAtellica IM HBcT2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur aHBe2 50T Kit — Siemens Healthcare Diagnostics Inc.ACCESS anti-HBc Total CALIBRATOR — Beckman Coulter, Inc.Atellica™ IM aHBs2 — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® HBc IgM — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® aHBs2 — Siemens Healthcare Diagnostics Inc.ACCESS anti-HBc Total QC — Beckman Coulter, Inc.IMMULITE® 2000 Systems aBC Anti-HBc — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAccess anti-HBc IgM Calibrator — Beckman Coulter, Inc.Atellica™ IM aHBs2 QC — Siemens Healthcare Diagnostics Inc.Atellica IM aHBe2 — Siemens Healthcare Diagnostics Inc.
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