Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Microbiology · 21 CFR 866.3173
In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.
Recent MDR events
4 adverse event reports on file
- Atellica IM HBc Total 2 (HBcT2)Jul 31, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00155
- Atellica IM HBc Total 2 (HBcT2)Jul 31, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00156
- ADVIA CENTAURApr 15, 2026MalfunctionSiemens Healthcare Diagnostics Inc.1219913-2026-00079
- ATELLICA IM HBC TOTAL 2 (HBCT2)Mar 23, 2026MalfunctionSiemens Healthcare Diagnostics Products Ltd.1219913-2026-00060
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
63 firms currently registered for this product code
Abbott Laboratories
Lake Forest, IL, US
Ortho-clinical Diagnostics
Pencoed Bridgend, GB
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Ortho Clinical Diagnostics
Singapore South West, SG
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Diasorin Italia S.p.a.
SALUGGIA Vercelli, IT
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Abbott Gmbh
Wiesbaden Hesse, DE
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Immunotech Sas, A Beckman Coulter Company
MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
510(k) clearances
4 clearances for this product code