IVD Assay Development
Basematrix Negative Diluent
            Material Number 
        1805-0076
    
                
            Size
        50 mL
    
            
                
            
                Inventory Status
                    
                        In Stock
                    
            
                
            Unit
        EA
    
            
        Details
                                Basematrix Negative Diluent is well suited, widely used and readily customizable for 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, anti-HBc, anti-HTLVI/II, HIV-1 RNA, HCV RNA and HBV DNA. 
                                                                                            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).>25>
Processing includes:
- Pooling into batches up to 300 Liters
- Removal of fibrinogen
- 0.2 µm 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: 501101

 
          
          

 
