Emergency Use Authorization from the FDA # 201039
CLIA Waived! – FDA Authorized for point of use!
NEW AND IMPROVED KITS!
- even higher specificity
- even higher sensitivity
- separate wells for sample and buffer solution
- clearer instructions
- standard, easy to use pipettes for sample transfer
Sensitivity 93.3%
Specificity 98.8%
95% Overall Accuracy
Use Whole Blood, Plasma or Serum
Fast & Easy Positive results as fast as 10 minutes) No Age Restriction
Room Temperature Storage
Product Code: CD-COV19 (20/bx) Contents: 20 Individually Pouched Test Cassettes. 1 Buffer Vial. 20 Disposable Plastic Capillaries. 1 Package Insert.
Clarity COVIBLOCK COVID19 IgG-IgM Antibody Test Package Insert 05152020
EUA201039.Acknowledgment Letter for Salofa Finland
EUA201039-Clarity-COVIBLOCK-Recipient-FS-07132020-FINAL
No returns on Covid-19 related items
