COVID-19 IgG/IgM Rapid Test Cassette
Lateral flow immunoassay cassette for detecting SARS-CoV-2 IgG and IgM antibodies in human serum, plasma or whole blood. This prepared diagnostic reagent on a backing qualifies for HTS 3822.19.00 as a laboratory test kit containing antibodies, buffers and detection reagents. Used in clinical labs for serological screening.
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More Specific Codes
This product may fall under a more specific subheading:
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If marketed as home-use self-test
Consumer self-testing diagnostic kits for retail sale are classified under therapeutic immunochemical products.
If assembled complete test instrument
Complete diagnostic instruments rather than just reagents fall under Chapter 90 medical instruments.
If simple paper-based lateral flow strips only
Basic test strips on cellulose backing without additional reagents use the specific backing subheading.
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Import Tips & Compliance
• Submit FDA Emergency Use Authorization (EUA) documentation if applicable to facilitate customs processing
• Verify all kit components are listed on commercial invoice to prevent partial reclassification
• Include performance validation data showing analytical sensitivity/specificity for customs verification
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