ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit

FDA premarket approval P210003 · decided 2022-08-10

Approval details

PMA number: P210003
Trade name: ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Applicant: Abbott Laboratories
Date received: 2021-02-08
Decision date: 2022-08-10
Days to decision: 548 days
Decision code: APRL
Product code: LOM
Advisory committee: Microbiology
Expedited review: No
Location: Abbott Park, IL
Statement: Approval for the ARCHITECT HBsAg NEXT Qualitative Reagent Kit. The HBsAg Next Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 years to 21 years of age) serum, serum separator tube, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, sodium heparin) on the ARCHITECT i System.The assay may also be used to screen for hepatitis B virus

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