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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

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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.

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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.

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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.

PregCheck+ procedure

# PC80200 Urine/Serum, Box of 25

PDF iconPregCheck+ Urine/Serum Product Insert