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Lateral Flow Rapid Test Strip Kit for Pregnancy from Japan

Immunochromatographic rapid test kit containing hCG detection strips, cassette housing, and reagents for urine pregnancy testing. Classified under HTS 3822.19.0080 as prepared diagnostic reagents on backing in kit form.

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

• FDA 510(k) clearance required for OTC home pregnancy tests; include package insert

• Specify nitrocellulose membrane backing material in technical description

• Avoid Chapter 30 classification by declaring as laboratory/IVD reagents, not consumer health products