Early Pregnancy Testing Qualitative rapid immunoassay tests based on the SAS™ colloidal gold t ­echnology for the determination of H ­ uman Chorionic ­ onadotropin ­ G (hCG) in serum or urine (a visual method) •  SAS™ One-Step Pregnancy •  SAS™ Serum/Urine hCG •  SAS™ Ultra hCG Serum/Urine •  SAS™ Pregnancy Strip Reliable Diagnostic Tests

• CLIA Classification: Waived • Simple to run with built-in control • Results within 4 minutes • Room temperature storage • 24-month shelf life Description SAS™ One-Step Pregnancy Application/Shelf Life Sensitivity, Specificity Results/ Minutes Detects hCG in urine (Shelf Life: 24 mos.) 25 mIU, 250 mIU, Negative, 3 Vials/Pk (NOTE: For use with 087525, 087430, 087730, 087750, 087731, and 087751) CLIA WAIVE Urine D/ Only • CLIA Classification: Waived for urine and non-waived for serum tests • Simple to run with built-in control • Results within 4 minutes • Room temperature storage • 21-month shelf...

Test Procedure Dropper The pouch must be at room temperature before opening to avoid condensation of moisture on the membrane. Allow specimen and/ or controls to reach room temperature prior to testing. 1. Remove the test device from the protective pouch and ­ place it on a flat surface. Label the device with patient or control identifications. 2. Dispense 3 to 4 drops (approximately 0.15 mL) of specimen into the round sample well (see illustration). Wait for colored lines to appear. Minutes/  Urine Minutes/  Serum SAS™ One-Step Pregnancy and SAS™ Serum/Urine hCG— Read serum and urine results...

• CLIA Classification: Waived • Simple to run with built-in quality control check • Results within 4 minutes or less • No pipetting or counting drops • Room temperature storage • 24-month shelf life Description SAS™ Pregnancy Strip Application/Shelf Life Sensitivity, Specificity Results/ Minutes Detects hCG in urine (Shelf Life: 24 mos.) 25 mIU, 250 mIU, Negative, 3 Vials/Pk (NOTE: For use with 087525, 087430, 087730, 087750, 087731, and 087751) Test Procedure 1. Dip test strip into the urine specimen. NOTE: Do not immerse the test strip beyond the “Stop Line.” 2. Leave the test strip immersed...