Good Things Come in All Packages

SRE0027 Heparin – ELITE Quality from Sigma-Aldrich

Are you Ready to Meet the FDA Guidance Document Requirements for Heparin?

The FDA is concerned about the safety and effectiveness of medical devices and IVD reagents that may be affected by Heparin with Oversulfated Chondroitin Sulfate (OSCS) and the effect these contaminants may have on the accuracy of In-Vitro Diagnostic (IVD) assays. To minimize the risk, the FDA is proposing a PCR based test to detect contamination of Heparin with OSCS. We have worked with our suppliers to ensure that the Heparin we supply to our IVD users and manufacturers meets the highest quality specification and testing requirements as outlined in the guidance document specified by the FDA (USP 37).

SRE0027 ELITE Heparin Sodium Salt from Porcine Intestinal Mucosa

  • Is purchased as USP grade material
  • Undergoes the FDA recommended PCR Test
  • Collection facilities are located in North American, Europe and South America; no China sourcing
  • Is internally monitored for purity and impurities by NMR and CHN

Which IVD Devices might be Affected – per FDA?

  • IVD’s that incorporate heparin as part of the device itself
  • IVD’s that use or rely on Heparin as part of the manufacturing process
  • IVD’s that are used to monitor Heparin that has been injected into patients