Tregzi Kit
Product Images NDC 85866-223

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tregzi (NDC 85866-223). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Orca Biosystems Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Tregzi 01)

A Kaplan-Meier survival curve graph displaying event-free probability over time from hematopoietic cell transplantation (HCT) in months. It compares TREGZI therapy with standard of care (SoC) control, showing higher event-free rates for TREGZI at month 12. The chart includes censored event markers and a risk table indicating the number of subjects at risk and events over time for both groups.*

FDA Label Image

Principal Display Panel (100 mL Bag Label)

Label for TREGZI, an allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq in a kit dosage form. The label details Step 1 of Administration focusing on the HSPC component, specifying storage conditions (2°C to 8°C) and usage instructions. Manufactured by Orca Biosystems, Inc., Menlo Park, CA, the label includes patient and lot identification fields, dosing guidance, and regulatory information.*

FDA Label Image

Principal Display Panel (100 mL Bag Label)

Text panel titled 'Step 2 of Administration: Treg Component' for allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (TREGZI). It includes handling instructions, storage temperature (2°C to 8°C), dosage guidance for infusion after Step 1, and patient identification fields. Manufactured by Orca Biosystems, Inc., Menlo Park, CA.*

FDA Label Image

Principal Display Panel (HSPC and Treg Bag Carton)

Carton label for TREGZI allogeneic regulatory T cell immunotherapy KIT from Orca Biosystems Inc. The label details a two-step product containing HSPC and Treg Components in single bags for infusion. Instructions for patient ID verification and storage at 2°C to 8°C are included. The label also features usage warnings, dosage form, and NDC 85866-123.*

FDA Label Image

Principal Display Panel (15 mL Bag Label)

Text panel titled 'Step 3a of Administration: Tcon Component' for allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (TREGZI). It details cell suspension for infusion instructions, storage conditions at -125°C in vapor phase of liquid nitrogen, dilution and dosage instructions, and patient ID placeholders. The label includes manufacturing and contact information for Orca Biosystems, Inc.*

FDA Label Image

Principal Display Panel (15 mL Casette Label)

Label panel for TREGZI allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq, Step 3a of Administration: Tcon Component, a cell suspension for infusion kit by Orca Biosystems Inc. The label includes storage instructions, dosage notes, recipient identification fields, and lot and expiration details. It emphasizes use for allogeneic intravenous infusion after dilution and storage in vapor phase liquid nitrogen.*

FDA Label Image

Principal Display Panel (38 mL Bag Label)

Drug administration instructions for TREGZI, allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq. The label specifies Step 3b, Tcon Diluent, for intravenous use only to dilute TREGZI Tcon Component. It includes storage guidelines, usage directions, and patient identification placeholders. Manufactured by Orca Biosystems, Inc., Menlo Park, CA.*

FDA Label Image

Principal Display Panel (38 mL Bag Carton)

Packaging label for TREGZI allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq kit by Orca Biosystems Inc. The label details Step 3b of administration: Tcon Diluent, a single-use bag containing 38 mL sterile multiple electrolytes injection with 2% HSA. It includes storage instructions, usage directions for intravenous use, and a patient ID verification section.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.