VD-DC Mass Spect Gold^® Serum

VD-DC Mass Spect Gold^® is human plasma that is processed according to a validated process, which removes the Vitamin D2 and Vitamin D3 to levels of < 1 ng/ml. The process maintains the inherent characteristics of the human plasma resulting 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 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.

VD-DC 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 Vitamin D mass spectrometry applications.
Common Uses: Base matrix for Vitamin D calibrators, controls, standards and linearity products.

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. This material was tested as stated above in the testing section. Nevertheless, product of human origin should be considered potentially infectious and handled according to universal precautions. The safe and responsible handling of the product listed above is the responsibility of the customer. We accept no liability for injury or illness resulting from the use and/or handling of the product. The customer assumes responsibility for the proper disposal of all materials in accordance with Federal and State Regulations.

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

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