FDA Product Code SCA: Multi-analyte Respiratory Virus Antigen Detection Test

Rapid antigen testing for multiple respiratory viruses simultaneously reduces the need for sequential single-pathogen tests. FDA product code SCA covers multi-analyte respiratory virus antigen detection systems.

These lateral flow or microfluidic assays simultaneously detect antigens from multiple respiratory pathogens — including influenza A/B, RSV, and SARS-CoV-2 — from a single nasal or nasopharyngeal swab, delivering results within 15-30 minutes without laboratory equipment.

SCA devices are Class II medical devices, regulated under 21 CFR 866.3987 and reviewed by the FDA Microbiology panel.

Leading manufacturers include ACON Laboratories, Inc., Wondfo USA Co., Ltd. and Ihealth Labs, Inc..