ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS

FDA premarket approval P060035 · decided 2007-11-06

Approval details

PMA number: P060035
Trade name: ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
Generic name: Qualitative and Quantitative Hepatitis B Virus Antibody assays
Applicant: Abbott Laboratories
Date received: 2006-12-01
Decision date: 2007-11-06
Days to decision: 340 days
Decision code: APRL
Product code: SEI
Advisory committee: Microbiology
Expedited review: No
Location: Abbott Park, IL
Statement: APPROVAL FOR THE ARCHITECT CORE-M REAGENT KITARCHITECT CORE-M CALIBRATORS ANDARCHITECT CORE-M CONTROLS. THE DEVICES IS INDICTED FOR: THE ARCHITECT CORE-M ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM OR PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. A TEST FOR IGM ANTI-HBC IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR

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