SeraCon™ II Negative Diluent

SeraCon II is an ideal negative diluent for use in assay development and manufacture of calibrators and controls. SeraCon II is derived from human plasma collected in FDA-licensed facilities and tested in accordance with FDA guidelines for viral markers. The plasma is tested by FDA approved methods and found non-reactive for HBsAg, anti-HIV1/2, anti-HCV, HIV-1 RNA, and HCV RNA. Each donor is tested and found negative for syphilis according to FDA guidelines. The plasma is processed in an FDA-registered, ISO-certified 13485 facility and retains lot-to-lot consistency of total protein (>6.0 g/dL) and fibrinogen (<25 mg dl).>

Processing includes:

• Pooling into batches up to 1,000 Liters
• Removal of fibrinogen
• 0.2 µm filtered and dialyzed to mimic a serum-like state

The processing steps allow for a clear matrix suitable for control and calibrator production. Customization available upon request.

For research use only. Not for use in diagnostic procedures. Reference Number: 22000