Mycoplasma Rapid Detection Kit (qPCR)

产品描述（Product Details）

To expedite in-process and lot-release testing, the Mycoplasma rapid detection kit, based on Nucleic Acid Amplification Technology (NAT), has been developed and validated to meet the requirements outlined in European Pharmacopeia Chapter 2.6. 7.

Combined with mycoplasma DNA Sample Preparation kit (OPA-E101), this kit sensitively and reliably detects mycoplasma contamination in biological products, meeting or exceeding the regulatory guidance of 10 CFU/mL. The assay eliminates the need for time-consuming culture-based methods, simplifying the mycoplasma testing process and yielding results in 2-2.5 hours with high efficiency.

应用说明（Application）

The kit is used for detection of mycoplasma contamination in biological product, cells and bioproduct media etc.

For use in quality control/manufacturing process only.

It is for research use only.

技术参数（Technical Specifications）

组分（Materials Provided）

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