SARS-CoV-2 Antigen Detection Kit from Japan
A diagnostic reagent kit containing SARS-CoV-2 spike protein antigens and monoclonal antibodies for rapid nasal swab testing. It falls under HTS 3822.19.0030 as it contains antigens for laboratory diagnosis of COVID-19 infection. Prepared as a complete test kit on a backing for point-of-care use.
Duty Rate — Japan → United States
12.5%
Rate breakdown
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter
Import Tips
• Obtain FDA 510(k) clearance or EUA documentation prior to import for diagnostic reagents
• Include detailed composition listing antigens/antisera and lot-specific certificates of analysis
• Avoid misclassification as consumer test kits under 3006 by emphasizing laboratory reagent status