IVD Assay Development
SeraCon™ I Negative Diluent
Material Number
1800-0009
Size
1 L
Inventory Status
Backorder: Available Soon
Unit
EA
Details
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).>25>
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