IVD Assay Development

SeraCon™ I Negative Diluent

Material Number 1800-0063
Size 3 L
Inventory Status In Stock
Unit EA
SeraCon I is an ideal negative diluent for use in assay development and manufacture. The product is formulated from human plasma collected in FDA-licensed facilities and tested in accordance with FDA guidelines for viral markers. The plasma is tested and found non-reactive for HBsAg, anti-HIV1/2, anti-HCV, HIV-1 RNA and HCV RNA.

Donors are tested and found negative for Syphilis per FDA guidelines. The plasma is processed in an FDA-registered, ISO-certified 13485 facility and retains lot-to-lot consistency of total protein (>6.0g/dL) and fibrinogen (<25 mg dl).>

Processing includes:

  • Pooling into batches up to 1,000 Liters
  • Removal of fibrinogen
  • 0.2 µm filtered that mimics a serum-like state that is optically clear

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: 21000-1L