DC Mass Spect Gold^® Serum

DC Mass Spect Gold is processed from human plasma through a validated process that reduces the Hormone and Steroid levels, please see values below. This validated process maintains the inherent characteristics of the human plasma resulting in a pool 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 and found negative for HIV1/2-ab, HBsAg, HCV-ab, HIV-1 (NAT), HCV (NAT) and RPR. The plasmais 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.

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

Common Uses: Base matrix for hormone and steroid calibrators, controls, standards and linearity products.

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