DDC Mass Spect Gold^® Serum

DDC Mass Spect Gold^® Serum is used as a zero base or in preparation of controls, calibrators and standards for Immunoassays, GCMS and LCMS applications and Hormone and Steroid mass spectrometry applications.
Common Uses: Base matrix for hormone and steroid calibrators, controls, standards and linearity products.

In-vitro use only. Products are intended for research or manufacturing of non-injectible products only.

DDC Mass Spect Gold^® is processed from human plasma using a validated process that reduces the hormone and steroid levels (please see average hormone and steroid values in the Certificate of Analysis). This process also 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 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.

Each Unit of plasma used in the preparation of this material was tested and found negative or non-reactive for HIV 1/2, HBsAg, HCV, HIV-1 (NAT), HCV (NAT) and RPR by FDA approved methods. Products are intended for research or manufacturing of non-injectable products only.

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