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NeoDx NeoDx

NeoDx

Precision Diagnostics: Reliable Results, Affordable Solutions

发布日期: 2024年6月13日
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Our BCR-ABL range of real-time PCR Kits has received the long-awaited CE-IVD Certification.???

CE marking indicates that an In-Vitro Diagnostics device complies with the European IVDD 98/79/EC/IVDR 2017/746.? While CE marking is required for all in vitro diagnostic (IVD) devices sold in Europe, Indian Regulations do not mandate CE Marking (while CDSCO approval is mandatory, CE Marking is valued by the customers).?

NeoDx’s BCR-ABL Real-time PCR kits for Qualitative or Quantitative detection of Chronic Myeloid Leukemia, Ph-Positive Acute Lymphoblastic Leukemia and Minimal Residual Disease (MRD) in a single-tube, multiplex kit format. Kit is CDSCO (Indian FDA Approved) and is CE-IVD Certified.
BCR-ABL Real-Time PCR kits are CDSCO-approved and CE-IVD Marked.

So, what does it mean for you??

The CE marking assures customers of product quality and clinical safety. The IVDR also requires companies manufacturing devices to implement a quality management system to ensure a high standard of quality throughout the product lifecycle.

At NeoDx, we are committed to meeting the highest quality standards, and as part of our work to become IVDR compliant, we solidified our Quality Management system by becoming an EN ISO 13485-certified facility since November 2023.

CE certification is evidence of compliance with current regulations and the standards that go with them. NeoDx, as a manufacturer of a CE-marked Real-Time PCR kit, validates and continues to enhance our products for their intended use and improves the product to ensure that they are safe, effective, and assure quality and performance.

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