IVD Assay Development

SeraCon™ II Negative Diluent

Material Number 1800-0012
Size 1 L
Inventory Status In Stock
Unit EA
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