Application

Zero base or in preparation of controls, calibrators and standards for Immunoassays, GCMS and LCMS applications and Vitamin D mass spectrometry application

General description

VD-DDC Mass Spect Gold^® is human plasma that is processed according to a validated process that removes the Vitamin D2 and Vitamin D3 to levels of ﹤1 ng/ml . This process maintains the inherent characteristics of the human plasma resulting a in a Vitamin D product that is consistent with patient samples. The human plasma is collected from donors at FDA licensed facilities. Each donor is screened for donor eligibility according to FDA regulations. Each unit is tested for and found negative for HIV1/2-ab, HBsAg, HCV-ab, HIV-1 (NAT), HCV (NAT) and RPR. The plasma is inspected for conformance to raw material specifications. The plasma is processed according to a batch record. The finished product is analyzed and inspected according to quality control procedures for conformance to specifications. Records from donor unit(s) to final product are maintained according to established procedures. These records include donor records, raw material inspection records, batch records, testing records (baseline through final product), labeling records, final product inspection records and batch release records.

Legal Information

Mass Spect Gold is a registered trademark of Golden West Biologicals, Inc.

Other Notes

Common Uses: Base matrix for Vitamin D calibrators, controls, standards and linearity products.