Image Description (Spl 1)
Lumisight Injection, Powder, Lyophilized, For Solution
Product Images NDC 82292-040
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Lumisight (NDC 82292-040). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Lumicell, 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.
Product Images & Figures Index
Image Description (Spl 2)
Image Description (Spl 3)
LUMISIGHT is an injectable medication containing 39 mg per vial of pegulicianine. After reconstitution with 0.45% Sodium Chloride Injection, USP, it is intended for intravenous use. The medication comes in packages of 10 single-dose vials. The reconstitution process involves adding 4 mL of the sodium chloride solution per vial for withdrawal of 3.9 mL. The product is distributed by LUMICELL and can be found at 275 Washington Street, Suite 20, Newton, MAT24545.*
Table1 (Table 1)
This is a table that shows the image-level performance of LUMISIGHT for detecting residual breast cancer in the lumpectomy cavity after the completion of standard care surgery. The table provides the number of positive and negative results from both LUMISIGHT and another imaging result, along with the total numbers. Additionally, it includes diagnostic performance metrics such as sensitivity and specificity, along with their confidence intervals. The study methodology involved regions of the lumpectomy cavity where LUMISIGHT-guided shaves were taken, and a statistical method was used to account for within-patient correlation when calculating sensitivity and specificity.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
