RhoGAM Human Immune Serum
RhoGAM is a human immune globulin derived from plasma containing antibodies against the Rho(D) antigen, used to prevent Rh hemolytic disease in newborns. It qualifies under HTS 3002.12.0030 as human immune blood sera prepared for prophylactic use in preventing alloimmunization in Rh-negative mothers. This sterile, injectable product is biotechnologically processed from human plasma.
Import Duty Rates by Country of Origin
| Origin Country | MFN Rate | Ch.99 Surcharges | Total Effective Rate |
|---|---|---|---|
| 🇨🇳China | Free | — | Free |
| 🇲🇽Mexico | Free | — | Free |
| 🇨🇦Canada | Free | — | Free |
| 🇩🇪Germany | Free | — | Free |
| 🇯🇵Japan | Free | — | Free |
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If derived from animal sources like equine plasma
Antisera from immunized animals (e.g., horse) fall under other blood fractions from animals, not human immune sera.
If unmodified human blood fractions without specific immune properties
Basic human blood fractions lacking targeted antisera activity are classified separately from immune-specific sera.
If presented as an immunological product like monoclonal antibodies
Recombinant or biotech-derived immunological products (e.g., MABs) shift to specific subheadings for non-sera biologics.
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Import Tips & Compliance
• Obtain FDA biologics license application (BLA) approval and ensure cold chain documentation for plasma products to maintain potency
• Provide certificates of analysis verifying human plasma origin and absence of adventitious agents per 21 CFR 630
• Avoid misclassification as non-immune sera; confirm immunological activity via donor screening records
Related Products under HTS 3002.12.00.30
HyperRAB Human Rabies Immune Globulin
HyperRAB is a purified human immune serum globulin providing passive rabies virus antibodies for post-exposure prophylaxis. Classified under HTS 3002.12.0030 as human immune blood sera due to its origin from plasma of rabies-vaccinated human donors. It is administered intramuscularly alongside vaccine for immediate protection.
Cytomegalovirus Immune Globulin Intravenous (CMV IGIV)
CMV IGIV is a human immune serum containing high-titer antibodies against cytomegalovirus, used prophylactically in transplant patients. It falls under HTS 3002.12.0030 as human immune blood sera fractionated from pooled plasma of immunized donors. The product is formulated for intravenous administration to prevent CMV disease.
Varicella Zoster Immune Globulin (VZIG)
VZIG is human immune serum globulin containing antibodies to varicella-zoster virus for post-exposure prophylaxis in immunocompromised patients. It is classified under HTS 3002.12.0030 as human immune blood sera from donors with recent varicella infection or vaccination. Administered intramuscularly within 96 hours of exposure.
Vaccinia Immune Globulin (VIG)
VIG is human immune serum globulin rich in antibodies against vaccinia virus, used to manage complications from smallpox vaccination. Under HTS 3002.12.0030 as human immune blood sera from donors vaccinated with vaccinia. It provides passive immunity via intravenous or intramuscular injection.
Hepatitis B Immune Globulin (HBIG)
HBIG is a human immune serum providing high-titer anti-HBs antibodies for post-exposure prophylaxis against hepatitis B virus. Classified in HTS 3002.12.0030 as human immune blood sera from HBV-vaccinated or recovered donors. It is essential for preventing mother-to-child transmission and needle-stick exposures.