A rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy. This test is for use in physicians' office and clinical laboratories.It is FDA Cleared and CLIA Waived for urine and CLIA Moderately Complex for Serum.

FDA 510K# K043385

Product Features and Specifications:

• Solid Phase sandwich format immunochromatographic assay.
  
• No reagents required.
  
• Serum or Urine Specimens.
  
• Specimen Delivered with a no drop counting pipette.
  
• Urine results in 3 minutes, Serum in 5.
  
• Urine sensitivity 20mIU/mL, Serum 10mIU/mL .
  
• Can be stored at room temperature.
  
• Shelf life of 12-18 months from manufacture date.
  
• Included user instructions

CPT Codes
81025 ($3.43 - $9.24)  Urine  (Waived)
84703 ($8.47 - $10.97) Serum  (Moderate)