Vitros Immunodiagnostic Products Anti-Hbc Reagent Pack/Calibrator

FDA premarket approval P030024 · Qualitative and Quantitative Hepatitis B Virus Antibody assays

PMA numberP030024

Approval

Applicant
Ortho-Clinical Diagnostics
Received
June 19, 2003
Decision date
March 4, 2004 (APRL)
Supplements
29, latest June 19, 2019
Product code
SEI – Qualitative And Quantitative Hepatitis B Virus Antibody Assays

Official FDA PMA record

Approval order statement

APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR. THESE DEVICES ARE INDICATED FOR: 1) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B CORE ANTIGEN (TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUM USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION. THE PRESENCE OF ANTI-HBC MAY BE USED AS AN AID IN THE DETERMINATION OF EXPOSURE TO HBV INFECTION FOR INDIVIDUALS PRIOR TO HBV VACCINATION. 2) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM WHEN USED FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B CORE ANTIGEN (TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUM USING VITROS ANTI-HBC REAGENT PACKS.