Batch QC analysis lookup
Every batch of Subcheck product undergoes rigorous quality control testing before release. Enter your lot number to view the complete QC report for your specific batch.
Quality assurance framework
Incoming Material Testing
All raw materials — antibodies, membranes, conjugate pads — tested against specifications before entering production. Vendor qualification maintained per ISO 13485.
In-Process Controls
Critical process parameters monitored during manufacturing: conjugate deposition volume, membrane wicking rate, line intensity calibration, and pouch seal pressure.
Finished Product Testing
Every lot tested for sensitivity across fentanyl analog panel, specificity against negative controls, accelerated stability, and physical integrity before release.
Stability Program
Real-time and accelerated stability studies per ICH Q1A guidelines. 24-month shelf life validated at 15-30°C storage. Annual stability reviews for each product line.
Traceability
Full lot-level traceability from raw material receipt through manufacturing, testing, packaging, and distribution to individual entity. Compliant with 21 CFR Part 820.
Continuous Improvement
CAPA system tracks all deviations and complaints. Quarterly management reviews. Annual internal audits. External audits by notified body per ISO 13485.