PregCheck+ Early Pregnancy Test for hCG in human urine/serum cleared for OTC use
Note: This device is FDA 510(k) cleared for over-the-counter use and CLIA waived.
The PregCheck+™ Early Pregnancy Test is designed for the rapid determination of human chorionic gonadotropin (hCG) in human urine/serum. These test kits are for professional use in obtaining a visual qualitative result for the detection of pregnancy. To conduct the test, four drops of specimen are dropped in the sample well of the cassette. Results are read at 5 minutes.
Interpret PregCheck+ Results
Positive: At 5 minutes, two pink colored bands appear, one in the Control region (C) and one in the Result region (R), indicate a positive result and that the specimen contains hCG level of 25 mIU/ml or greater.
Negative: At 5 minutes, only one pink colored band appears in the Control region (C) indicating a negative result and that the specimen contains hCG level of less than 25 mIU/ml.
Invalid: At 5 minutes, if no bands appear, or a Result (R) band appears without a Control (C) band, the result is invalid and the test should be repeated using a new device.
# PC80200 Urine/Serum, Box of 25