Immunological products, put up in measured doses or in forms or packings for retail sale

3002.13.00Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale

3002.14.00Immunological products, mixed, not put up in measured doses or in forms or packings for retail sale

3002.15.00Immunological products, put up in measured doses or in forms or packings for retail sale

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Products classified under Tariff item 3002.1

Anti-Rh(D) Immunoglobulin Injection

Anti-Rh(D) immunoglobulin injection is a blood fraction containing antibodies against the Rh(D) antigen, derived from human plasma. It is administered prophylactically to prevent hemolytic disease of the newborn in Rh-negative mothers. This product is classified under tariff item 3002.12.00 as an antiserum prepared for therapeutic use.

Botulinum Toxin Type A Immune Globulin

Botulinum toxin type A immune globulin is an antitoxin derived from human plasma fractions containing antibodies against botulinum toxin. It is used to treat infant botulism by neutralizing the toxin. This product falls under tariff item 3002.12.00 as an immunological blood fraction for therapeutic neutralization.

Botulism Antitoxin (Trivalent, Equine)

Botulism Antitoxin (Trivalent, Equine) is an antiserum derived from equine plasma containing antibodies that neutralize botulinum neurotoxins A, B, and E. It is used therapeutically for the treatment of botulism poisoning. This product falls under tariff item 3002.12.00 as an antiserum prepared for therapeutic uses.

Cryoprecipitated Antihemophilic Factor from Human Plasma

Cryoprecipitated Antihemophilic Factor from Human Plasma is a human plasma fraction rich in factor VIII, fibrinogen, and von Willebrand factor. It is prepared by thawing frozen plasma at 1-6°C and used to treat hemophilia A and fibrinogen deficiencies. This product falls under tariff item 3002.12.00 as a blood fraction for therapeutic use.

Cytomegalovirus (CMV) Hyperimmune Globulin

Cytomegalovirus (CMV) hyperimmune globulin is a plasma fraction enriched with CMV-specific antibodies, used to prevent CMV infection in transplant patients. It is prepared from pooled human plasma of donors with high antibody titers. This product is classified under tariff item 3002.12.00 as a blood fraction prepared for prophylactic use.

Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV)

Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV) is a purified immunoglobulin fraction derived from human plasma of donors with high CMV antibody titers. It is used prophylactically to prevent CMV infection in transplant patients. This product falls under tariff item 3002.12.00 as a blood fraction prepared for therapeutic or prophylactic uses.

Cytomegalovirus Immune Globulin Intravenous (CMV IGIV)

Cytomegalovirus Immune Globulin Intravenous (CMV IGIV) is a human immune serum containing high-titer antibodies against cytomegalovirus, used prophylactically in transplant patients. It falls under tariff item 3002.12.00 as human immune blood sera fractionated from pooled plasma.

Diphtheria Antitoxin (Equine)

Diphtheria Antitoxin (Equine) is an antiserum derived from equine plasma containing antibodies against diphtheria toxin. It is used therapeutically for severe cases of diphtheria unresponsive to antibiotics. This product falls under tariff item 3002.12.00 as an antiserum prepared for therapeutic use.

Fetal Bovine Serum (FBS) Australian Origin

Fetal Bovine Serum (FBS) Australian Origin is collected from BSE-free regions and processed for high-quality cell culture in vaccine manufacturing and diagnostics. Under tariff item 3002.12.00, it is classified as a therapeutic animal blood fraction.

Fetal Bovine Serum (FBS) Charcoal-Stripped

Fetal Bovine Serum (FBS) Charcoal-Stripped has hormones and steroids removed via charcoal treatment, used in endocrine research and therapeutic cell therapies. It qualifies for tariff item 3002.12.00 as a specialized fetal bovine blood fraction for therapeutic and diagnostic applications.

Fetal Bovine Serum (FBS) Classic Grade

Fetal Bovine Serum (FBS) Classic Grade is derived from the blood of bovine fetuses and processed to provide essential growth factors for cell culture in therapeutic, prophylactic, and diagnostic applications. It falls under tariff item 3002.12.00 as a prepared animal blood fraction.

Fetal Bovine Serum (FBS) Dialyzed

Fetal Bovine Serum (FBS) Dialyzed is processed through dialysis to remove small molecules, ideal for sensitive cell culture in diagnostic assays and vaccine production. Classified under tariff item 3002.12.00 due to its role as a specialized animal blood fraction.

Fetal Bovine Serum (FBS) Gamma-Irradiated

Gamma-irradiated fetal bovine serum (FBS) is a blood fraction derived from bovine fetuses, processed with gamma radiation to inactivate potential viral contaminants. It is used as a cell culture supplement in gene therapy research and diagnostic applications. This product falls under tariff item 3002.12.00 as a modified animal blood fraction prepared for therapeutic or prophylactic uses.

Fetal Bovine Serum (FBS) New Zealand Sourced

New Zealand-sourced fetal bovine serum is a blood fraction obtained from bovine fetuses in New Zealand, a country certified as low-risk for bovine spongiform encephalopathy (BSE). It is used to support stem cell therapies and immunological product testing. This product is classified under tariff item 3002.12.00 as a prepared fetal blood fraction for biotechnological processes.

Fetal Bovine Serum (FBS) USP Grade

USP-grade fetal bovine serum is a high-purity blood fraction meeting United States Pharmacopeia standards, used for clinical-grade cell expansion in regenerative medicine. It is processed to ensure consistency and low endotoxin levels. This product falls under tariff item 3002.12.00 as a prepared blood fraction for therapeutic applications.

Freeze-Dried Normal Human Blood Serum

Freeze-Dried Normal Human Blood Serum is obtained from healthy human donors and processed to remove water while preserving proteins and antibodies. It falls under tariff item 3002.12.00 as a normal human blood serum prepared for therapeutic, prophylactic or diagnostic uses.

Fresh Frozen Human Plasma

Fresh Frozen Human Plasma is obtained from whole human blood and frozen within 8 hours of collection to preserve clotting factors. It is used therapeutically for patients with coagulopathies or massive transfusion needs. This product falls under tariff item 3002.12.00 as a blood fraction prepared for therapeutic uses.

Hepatitis B Immune Globulin (HBIG)

Hepatitis B Immune Globulin (HBIG) is a human plasma-derived blood fraction rich in antibodies to hepatitis B surface antigen. It is used for post-exposure prophylaxis against hepatitis B infection. This product falls under tariff item 3002.12.00 as an antiserum for therapeutic and prophylactic applications.

Human Anti-D Immunoglobulin

Human Anti-D Immunoglobulin is a blood fraction derived from human plasma containing antibodies against the D antigen on red blood cells. It is used prophylactically to prevent Rh incompatibility in pregnancies. This product falls under tariff item 3002.12.00 as a blood fraction prepared for therapeutic or prophylactic uses.

Human Immunoglobulin G (IgG) Concentrate

Human immunoglobulin G (IgG) concentrate is a purified fraction of human blood plasma containing high levels of IgG antibodies. It is used therapeutically to treat primary immunodeficiencies and autoimmune disorders. This product falls under tariff item 3002.12.00 as a blood fraction prepared for therapeutic use.

Human Immunoglobulin G (IgG) Intravenous

Human Immunoglobulin G (IgG) Intravenous is a pooled blood fraction from human plasma containing primarily IgG antibodies. It is used therapeutically for immune deficiencies and autoimmune disorders. This product falls under tariff item 3002.12.00 as a blood fraction prepared for therapeutic uses.

Human Plasma-Derived Immunoglobulin Fraction

Human Plasma-Derived Immunoglobulin Fraction is a pooled human plasma fraction containing antibodies for immune deficiency treatment. It is prepared via cold ethanol fractionation and retains blood fraction classification. This product falls under tariff item 3002.12.00 as a blood fraction for therapeutic use.

Human Plasma for Further Manufacture

Human Plasma for Further Manufacture is bulk human plasma supplied to fractionators for producing albumin, IVIG, and clotting factors. It is prepared with therapeutic end-use in mind. This product falls under tariff item 3002.12.00 as blood plasma for therapeutic applications.

HyperRAB Human Rabies Immune Globulin

HyperRAB Human Rabies Immune Globulin is a purified human immune serum globulin providing passive rabies virus antibodies for post-exposure prophylaxis. Classified under tariff item 3002.12.00 as human immune blood sera due to its origin from plasma of rabies-vaccinated donors.

IVIG for Guillain-Barré Syndrome

IVIG for Guillain-Barré syndrome is an intravenous immunoglobulin product pooled from thousands of donors, used to treat autoimmune neuropathies. It is a modified blood fraction with therapeutic anti-inflammatory properties. This product is classified under tariff item 3002.12.00 as a blood fraction for therapeutic use.

Liquid Normal Human Blood Serum for Cell Culture

Liquid Normal Human Blood Serum for Cell Culture is pooled from screened donors and heat-inactivated for use in mammalian cell culture. It is classified under tariff item 3002.12.00 as an unmodified normal human blood serum prepared for therapeutic, prophylactic or diagnostic uses, including research applications.

Lyophilized Human Plasma for Surgical Use

Lyophilized Human Plasma for Surgical Use is dehydrated plasma reconstituted with sterile water for volume replacement in surgery. It provides essential proteins and clotting factors. This product falls under tariff item 3002.12.00 as a blood fraction for therapeutic use.

Lyophilized Human Plasma Serum Pool

Lyophilized Human Plasma Serum Pool is freeze-dried normal serum from screened donors for long-term storage in laboratories. It fits tariff item 3002.12.00 as normal human blood sera prepared for diagnostic purposes such as ELISA blocking.

Monoclonal Antibody Infliximab Biosimilar

Monoclonal antibody infliximab biosimilar is a biotechnologically produced chimeric antibody targeting TNF-alpha, used to treat inflammatory conditions like Crohn's disease. It is produced by recombinant DNA technology and is a therapeutic biological product. This product falls under tariff item 3002.12.00 as an immunological product, per Chapter 30 note 2.

Normal Human Serum AB Positive

Normal Human Serum AB Positive is sourced from type AB donors, valued for low isoagglutinin levels in sensitive assays. Under tariff item 3002.12.00, it qualifies as normal human blood sera for diagnostic and research uses.

Pathogen-Reduced Human Plasma

Pathogen-Reduced Human Plasma is human plasma treated with amotosalen/UVA light to inactivate viruses, bacteria, and parasites while preserving therapeutic proteins. It is used for transfusion in immunocompromised patients. This product falls under tariff item 3002.12.00 as a modified blood fraction for therapeutic use.

Pooled Heat-Inactivated Human Blood Serum

Pooled Heat-Inactivated Human Blood Serum is derived from multiple donors to ensure consistency for laboratory applications. It is classified in tariff item 3002.12.00 as normal human blood sera, whether or not freeze-dried, prepared for therapeutic or diagnostic uses.

Quarantined Human Plasma Pool

Quarantined Human Plasma Pool is pooled human plasma held in quarantine pending complete viral testing before release for fractionation. It is therapeutic source material. This product falls under tariff item 3002.12.00 as plasma prepared for therapeutic uses.

Rabies Immune Globulin (Human)

Rabies Immune Globulin (Human) is a human-derived antiserum providing passive immunity against rabies virus post-exposure. It consists of purified IgG antibodies from vaccinated donors. This product falls under tariff item 3002.12.00 as an antiserum and blood fraction for prophylactic use.

RhoGAM Human Immune Serum

RhoGAM Human Immune Serum 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 tariff item 3002.12.00 as human immune blood sera prepared for therapeutic use.

Solvent/Detergent Treated Human Plasma

Solvent/Detergent Treated Human Plasma is human plasma treated with TNBP/Tween 80 to inactivate lipid-enveloped viruses, then purified for transfusion medicine. It qualifies as a human blood fraction under tariff item 3002.12.00 because the viral inactivation process does not alter its essential character as a blood-derived therapeutic product.

Tetanus Immune Globulin (Human)

Tetanus Immune Globulin (Human) is a human blood fraction containing high-titer antibodies against tetanus toxin. It is used for passive immunization in wound management. This product falls under tariff item 3002.12.00 as an antiserum prepared for therapeutic and prophylactic purposes.

Tetanus Immune Globulin (TIG)

Tetanus immune globulin (TIG) is a human blood fraction providing passive immunity against tetanus toxin, used for wound management. It is prepared by hyperimmunizing donors and fractionating plasma to concentrate tetanus antibodies. This product is classified under tariff item 3002.12.00 as an antiserum prepared for therapeutic use.

Vaccinia Immune Globulin (VIG)

Vaccinia Immune Globulin (VIG) is human immune serum globulin rich in antibodies against vaccinia virus, used to manage complications from smallpox vaccination. Under tariff item 3002.12.00, it is classified as human immune blood sera from donors vaccinated with vaccinia.

Varicella Zoster Immune Globulin (VZIG)

Varicella Zoster Immune Globulin (VZIG) is human immune serum globulin containing antibodies to varicella-zoster virus for post-exposure prophylaxis in immunocompromised patients. It is classified under tariff item 3002.12.00 as human immune blood sera from donors with high antibody titers.

Adalimumab High-Concentration Solution

Adalimumab high-concentration solution is a fully human monoclonal antibody against TNF-alpha, used for autoimmune diseases like psoriasis. As an aqueous solution of an unmixed product, it is treated as unmixed under chapter note 3(a)(1) and qualifies for tariff item 3002.13.00.

Adalimumab Monoclonal Antibody

Adalimumab is a fully human monoclonal antibody that targets tumor necrosis factor-alpha (TNF-alpha) and is used to treat autoimmune conditions such as rheumatoid arthritis and Crohn's disease. This product is imported in bulk, unmixed form, not put up in measured doses or retail packaging, which qualifies it under tariff item 3002.13.00 as an immunological product.

Atezolizumab Monoclonal Antibody

Atezolizumab is a humanized IgG1 monoclonal antibody that blocks PD-L1 and is used in the treatment of bladder cancer and other malignancies. Imported as an unmixed bulk substance without measured doses or retail packaging, it falls under tariff item 3002.13.00 as an immunological product obtained by biotechnological processes.

Bevacizumab Monoclonal Antibody

Bevacizumab is a humanized monoclonal antibody that binds vascular endothelial growth factor (VEGF) and is used to treat colorectal and lung cancers. This bulk, unmixed product is not in measured doses or retail packaging, making it classifiable under tariff item 3002.13.00 as an immunological product.

Blinatumomab Monoclonal Antibody

Blinatumomab is a bispecific T-cell engager (BiTE) monoclonal antibody used for the treatment of acute lymphoblastic leukemia. As an unmixed biotechnological product not put up in measured doses or retail sale forms, it is classified under tariff item 3002.13.00.

Bulk Colony Stimulating Factor G-CSF

Bulk Colony Stimulating Factor G-CSF (Filgrastim) is a recombinant protein that stimulates neutrophil production, primarily used post-chemotherapy. It is an unmixed immunological product, not put up in measured doses or for retail sale, and is classified under tariff item 3002.13.00 as per Chapter 30 Note 2, which covers colony stimulating factors.

Bulk Filgrastim

Bulk Filgrastim is a recombinant granulocyte colony-stimulating factor (G-CSF) analog that stimulates the production of neutrophils. It is an unmixed immunological product, not put up in measured doses or retail packaging, and is intended for further formulation. It falls under tariff item 3002.13.00 as a hematopoietin directly involved in the regulation of immunological processes.

Bulk Granulocyte Colony Stimulating Factor (G-CSF)

Bulk Granulocyte Colony Stimulating Factor (G-CSF) is a recombinant protein that promotes the production of neutrophils, classified as a hematopoietin under the chapter notes. It is supplied unmixed, without measured doses or retail packaging, and is used as an active pharmaceutical ingredient. This product falls under tariff item 3002.13.00 as an unmixed immunological product.

Bulk Infliximab

Bulk Infliximab is a chimeric monoclonal antibody against tumor necrosis factor (TNF), used in the treatment of autoimmune diseases. It is an unmixed immunological product, not put up in measured doses or retail packaging, and is intended for further manufacturing. It qualifies under tariff item 3002.13.00 as an antibody directly involved in the regulation of immunological processes.

Bulk Interferon Alpha-2a

Bulk Interferon Alpha-2a is a recombinant cytokine protein used for antiviral and anticancer treatment. It is an unmixed immunological product, not put up in measured doses or retail packaging, and is intended for further formulation. It falls under tariff item 3002.13.00 as an interferon directly involved in the regulation of immunological processes.

Bulk Pembrolizumab

Bulk Pembrolizumab is a PD-1 inhibitor monoclonal antibody used in immuno-oncology. It is an unmixed immunological product obtained by biotechnological processes, not in measured doses or retail packs, and is classified under 3002.13.00 per Chapter 30 Note 2.

Bulk Rituximab Immunological Product

Bulk Rituximab is a chimeric monoclonal antibody targeting CD20 on B-cells, used in lymphoma and autoimmune disease therapy. It is an unmixed immunological product produced via biotechnological processes, not for retail sale, and is classified under 3002.13.00.

Bulk Rituximab Monoclonal Antibody

Bulk Rituximab Monoclonal Antibody is a chimeric antibody targeting CD20 on B-cells, used for lymphoma and autoimmune disease treatment. It is an unmixed immunological product, not put up in measured doses or retail packaging, and is intended for further manufacturing. It qualifies under tariff item 3002.13.00 as an antibody directly involved in the regulation of immunological processes.

Bulk Trastuzumab Emtansine Conjugate

Bulk Trastuzumab Emtansine is an antibody-drug conjugate (ADC) combining a monoclonal antibody with a chemotherapy agent for HER2-positive breast cancer. It is an unmixed immunological product under 3002.13.00, as it is not put up in measured doses or retail packs.

Cetuximab Bulk Active

Cetuximab Bulk Active is a monoclonal antibody targeting EGFR for colorectal cancer treatment. It is an unmixed immunological product produced biotechnologically, not in measured doses or retail packaging, and is classified under 3002.13.00.

Cetuximab Monoclonal Antibody

Cetuximab is a chimeric monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is used in colorectal and head-and-neck cancer therapy. Imported in bulk, unmixed form without retail packaging, it falls under tariff item 3002.13.00 as an immunological product.