IVD Assay Development

SeraCon™ II CD Hormone Depleted Double-Stripped Negative Diluent

Material Number 1800-0035
Size 3 L
Inventory Status In Stock
Unit EA
SeraCon II CD Hormone Depleted Double-Stripped diluent is well suited for use in assay development and manufacture. The diluent 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-HIV 1/2, 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 with total protein (>6.0 g/dL), fibrinogen (<25 mg dl), and cholesterol triglycerides (><20 mg dl).>

Processing includes:

  • Pooling into batches up to 1,000 Liters
  • Removal of fibrinogen
  • Removal of lipids
  • Charcoal stripped twice for hormone depletion
  • 0.2 um filtered and dialyzed to mimic a serum-like state

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

For research use only. Not for use in diagnostic procedures.

Reference number: 22011-P