Hepatitis B Surface Antigen Test Kit
A diagnostic kit containing hepatitis B surface antigens (HBsAg) for patient administration in challenge tests to detect immune response. Classified under HTS 3006.30.10.00 as diagnostic reagents with antigens put up in measured doses for direct patient use. It aids in confirming immunity status post-vaccination.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If used as vaccine for active immunization against hepatitis B
Vaccines containing viral antigens for immunization are in 3002.13, distinct from patient-administered diagnostic reagents
If in vitro diagnostic reagent not administered to patient
Diagnostic reagents of heading 3822 exclude those designed for direct patient administration as per chapter notes
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Import Tips & Compliance
• Include FDA Investigational New Drug (IND) if for clinical trials; standard kits need 510(k)
• Provide stability and potency test results; customs may inspect for degradation
• Label as 'for diagnostic use only' to prevent reclassification as therapeutic vaccine
Related Products under HTS 3006.30.10.00
Rabies Vaccine for Human Use
This diagnostic reagent contains inactivated rabies virus antigens used for pre-exposure prophylaxis and post-exposure treatment in humans. It falls under HTS 3006.30.10.00 as it is a preparation containing antigens designed to be administered to the patient for immunological testing or vaccination. The product is put up in measured doses for direct injection.
Allergy Skin Test Antigens Panel
Panel of purified antigens from common allergens (dust mites, pollen, molds) for intradermal skin testing in patients. This product is classified in HTS 3006.30.10.00 as it contains antigens for diagnostic reagent administration to detect hypersensitivity. Supplied in sterile, measured doses for immediate use.
Tuberculin PPD Skin Test Solution
Purified protein derivative (PPD) from Mycobacterium tuberculosis antigens for Mantoux intradermal testing. Falls under HTS 3006.30.10.00 as a diagnostic reagent containing antigens administered to patients in measured doses for tuberculosis screening. Essential for latent TB detection.
Anti-D Antisera for RhoGAM Testing
Human anti-D (Rh) antisera used in diagnostic rosette tests to detect fetal-maternal hemorrhage. Classified under HTS 3006.30.10.00 as it contains antisera as diagnostic reagent administered to patient blood samples. Put up in measured doses for laboratory-to-patient testing protocol.
Streptolysin O Antigen Test Reagent
Streptolysin O antigens for ASO (anti-streptolysin O) titer diagnostic testing via patient serum reaction. This falls under HTS 3006.30.10.00 as a diagnostic reagent containing bacterial antigens designed for patient-related administration in clinical protocols. Supplied in single-use vials.
Influenza Antigen Challenge Kit
Live attenuated influenza antigens for nasal challenge in immunity diagnostic studies. Classified in HTS 3006.30.10.00 as diagnostic reagents containing viral antigens administered directly to patients. Used in clinical trials for vaccine efficacy testing.