Architect Hbsag Qualitative, Qualitative Confirmatory, Confirmatory Manual Diluent, Calibrators, and Controls

Approval order statement

APPROVAL FOR THE ARCHITECT HBSAG QUALITATIVE, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY MANUAL DILUENT, ARCHITECT HBSAG QUALITATIVE CALIBRATORS, AND ARCHITECT HBSAG QUALITATIVE CONTROLS. THIS DEVICE IS INDICATED FOR: ARCHITECT HBSAG QUALITATIVE - THE ARCHITECT HBSAG QUALITATIVE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA AND NEONATE SERUM. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK FOR ACQUIRING HEPATITIS BDURING THE PERINATAL PERIOD. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION. NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS. ARCHITECT HBSAG QUALITATIVE CONFIRMATORY - THE ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA AND NEONATE SERUM BY MEANS OF SPECIFIC ANTIBODY NEUTRALIZATION. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION. NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS. (FOR ADDITIONAL INFORMATION, PLEASE REFER TO APPROVAL ORDER).