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ACCESS HBsAg Confirmatory
Beckman Coulter, Inc. · Model D22914 · UDI-DI 15099590806262
Prescription
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510(k) clearances
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Adverse events
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Recalls
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Facilities
Description
The Access HBsAg Confirmatory assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human pediatric (7 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] that have been found to be repeatedly reactive in the Access HBsAg assay using the DxI 9000 Access Immunoassay Analyzer.
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