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N333558 · 2023-06-27 — The tariff classification of ELOCTATE® [Antihemophilic factor (recombinant), Fc fusion protein] in dosage form, from the United States
ELOCTATE, [Antihemophilic factor (recombinant), Fc fusion protein], is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for the on-demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes. Eloctate is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal potencies of 250, 500, 750, 1000,…
N304133 · 2019-11-04 — The tariff classification of Andexanet Alfa in bulk form, from Spain
, you requested a tariff classification ruling. We apologize for the delay as the information was sent to our laboratory for analysis. Andexanet alfa is an inactivated coagulation Factor Xa protein indicated for patients treated with anticoagulants rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening and uncontrolled bleeding. According to our laboratory, Andexanet alfa is a modified form of blood coagulation Factor Xa that is produced by biotechnological processes. The applicable subheading for the Andexanet alfa in bulk form will be 3002.12.0090,…
N294982 · 2018-08-03 — The tariff classification of IgG Rabbit Gamma Globulin (Millipore Cat #PP63-K). No country of origin was provided.
We apologize for the delay as the information was sent to our laboratory for analysis. The IgG Rabbit Gamma Globulin (Millipore Cat #PP63-K) consists of a mixture of purified rabbit immunoglobulin in a phosphate buffer solution. The IgG Rabbit Gamma Globulin will be imported in liquid form at concentrations of 53.6 mg/mL packaged for retail sale in 1 gram pack size. In your letter, you state this product will be used by IVD (in vitro diagnostics) manufacturers. According to our laboratory, the product is composed of IgG, purified from rabbit blood and is considered to be an other blood…
H259355 · 2017-12-19 — Request for a ruling; Classification of reference materials used in VITROS systems
(“requestor” or “OCD”). You request a ruling concerning the classification of eight reference materials used to calibrate, verify the calibration range, and monitor the performance of OCD’s VITROS Immunodiagnostic Systems under the Harmonized Tariff Schedule of the United States (“HTSUS”). FACTS: OCD requests a classification ruling on the following eight items: Intact PTH Control #6802895, Folate Range Verifiers #6800873, Troponin I ES Range Verifiers #6802303, Ferritin Calibrators #6800378 or #1158864, Anti-HIV 1+2 Calibrators #6801862, VITROS Immunodiagnostic Products Testosterone…
N283856 · 2017-03-22 — The tariff classification of Advate®, Obizur® and Vonvendi® imported in dosage form
The first product, Advate®, contains human recombinant Antihemophilic Factor VIII, as the active ingredient. It is indicated for the treatment of hemophilia A (congenital factor VIII deficiency) in children and adults. Specifically, it is used to replace clotting factor VIII that is missing in people with hemophilia A. Advate is available in dosage form as a lyophilized powder put up in vials that must be reconstituted with sterile water before administration by intravenous injection. The second product, Obizur®, contains Antihemophilic Factor VIII – recombinant (Porcine Analogue (rpFVIII),…
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