Cryoprecipitated Antihemophilic Factor from Human Plasma
Cryoprecipitate is a human plasma fraction rich in factor VIII, fibrinogen, and von Willebrand factor, prepared by thawing frozen plasma at 1-6°C. It treats hemophilia A and fibrinogen deficiencies. Falls under HTS 3002.12.00.10 as a human blood fraction derived from plasma.
Import Duty Rates by Country of Origin
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If presented as a highly purified single-factor concentrate
Purified coagulation factor concentrates may shift to vaccines/toxins/cultures heading.
If for retail-dispensed diagnostic plasma preparations
Medicaments mixed for direct patient diagnostic use classify in Chapter 30 heading 3004.
If purely diagnostic reagents without therapeutic claim
Diagnostic-only blood plasma excludes from Chapter 30 per chapter note (i).
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Import Tips & Compliance
• Provide CBER registration and lot-specific release certificates from FDA-licensed fractionators
• Declare exact protein content and potency per unit to avoid misclassification during entry
• Watch for expiration dating issues; expired plasma risks waste pharmaceutical classification under 3006
Related Products under HTS 3002.12.00.10
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. Classified under HTS 3002.12.00.10 as human blood plasma prepared for therapeutic uses.
Human Plasma-Derived Immunoglobulin Fraction
IVIG (intravenous immunoglobulin) is a pooled human plasma fraction containing antibodies for immune deficiency treatment. Prepared via cold ethanol fractionation. While purified, retains blood fraction classification under HTS 3002.12.00.10.
Human Plasma for Further Manufacture
Bulk human plasma supplied to fractionators for producing albumin, IVIG, and clotting factors. Prepared with therapeutic end-use in mind. Classified HTS 3002.12.00.10 as blood plasma for therapeutic applications.
Lyophilized Human Plasma for Surgical Use
Lyophilized (freeze-dried) human plasma is dehydrated plasma reconstituted with sterile water for volume replacement in surgery. It provides essential proteins and clotting factors. Classified in HTS 3002.12.00.10 as processed human blood plasma for therapeutic applications.
Pathogen-Reduced Human Plasma
Human plasma treated with amotosalen/UVA light to inactivate viruses, bacteria, and parasites while preserving therapeutic proteins. Used for transfusion in immunocompromised patients. HTS 3002.12.00.10 covers this modified human blood plasma.
Solvent/Detergent Treated Human Plasma
Human plasma treated with TNBP/Tween 80 to disrupt lipid envelopes of viruses, then purified. Used for transfusion medicine. Classifies as human blood fraction under HTS 3002.12.00.10 despite viral inactivation processing.