(25 Tests) The Instant-View Pregnancy Urine Test Cassette, is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. FDA Cleared and CLIA Waived. (FDA 510K#: K984076)
- Method: Lateral flow test
- Cut-off level: 25 mIU/mL
- Accuracy: > 99%
- Sample: Urine
- Read time: 2-5 minutes
- Storage: Room temperature
- Shelf life: 12-18 months from date of manufacture
- CLIA Classification: Waived
- 25 mIU/ml sensitivity
- Over 99% accurate & over 99% specificity
- Simple, one-step procedure
- 12-18 mo. shelf-life at room temperature (from date of manufacture)
- Small sample volume required
- CLIA-waived status
- Assigned CPT codes: 81025
- Made in U.S.A.
- Can detect pregnancy as early as first day of missed period
- Outstanding performance on a par with higher-priced tests
- Quick results; minimizes user error
- No special storage requirements to maintain stability
- Sample can be run reliably with minimal amount of specimen
- No special training required
- Accepted by Medicare for reimbursement
- Consistent, on-time supply & ready technical support
