REAGENTS

Reagents are manufactured in compliance with Good Manufacturing Practices (GMPs). All reagent labels are serially barcoded allowing the analyzer to detect when a new lot of reagent is being used. In the unlikely event that a barcode is damaged and not able to be scanned by the barcode reader, a reagent bottle with an intact barcode would need to be used.

Customers are required to sign up for a standing order for XW QC CHECK that is shipped every 28 days. Reagents are reordered as needed. The XW-100 tracks all lot numbers and expiration dates via barcodes on each product.

XW QC CHECK is to be stored at 15 to 25°C at the CLIA-waived site and is stable for 30 days. XW QC CHECK is shipped to customers every 28 days.

QC is not required when the same lot of reagent is connected to the analyzer. The analyzer will require QC to be run when a new lot of reagent is connected to the analyzer. All reagent labels are serially barcoded allowing the analyzer to detect when a new lot of reagent is being used.