SAFENSURE™ Recombinant Factor C Endotoxin Detection Kit (High Sensitivity)

产品概述（Product Overview）

The Recombinant Factor C (rFC) Endotoxin Detection Kit is an advanced, animal-free method for sensitive and specific detection of bacterial endotoxins. Recombinant Factor C, the endotoxin-responsive component of the horseshoe crab coagulation cascade, is produced using recombinant technology and selectively activated by endotoxin.Upon activation, rFC cleaves a fluorogenic substrate, generating a fluorescent signal proportional to the endotoxin concentration. The assay provides a broad quantitative detection range of 0.001–10 EU/mL, enabling reliable measurement from ultra-low to high endotoxin levels.Unlike traditional LAL assays, the rFC method is not susceptible to β-glucan–induced false positive interference, ensuring improved specificity.The assay is performed in a white 96-well microplate. Fluorescence is measured at time zero and after 1 hour of incubation at 37°C using a fluorescence microplate reader (Ex/Em = 380/440 nm). Endotoxin contamination is determined based on the increase in fluorescence intensity relative to standards.

应用说明（Application）

Production process (Process control)

Raw materials

Water testing

Intermediate product testing

Final product (Release testing)

Parenteral drugs & Biological products

Infusion, injection or tranfusion cells

Cell culture media

Medical devices

It is for research use only.

存储（Storage）

1. Store the unopened kit at 2-8°C upon receipt.

2. Locate the expiration date on the outer packaging and do not use reagents beyond their expiration date.

质量管理控制体系（QMS）

1. 质量管理体系（ISO, GMP）
2. 质量优势
3. 质控流程