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• CorDx Ovulation Test strip, cassette and midstream are approved by CE. The first date of market introduction in EU was December 2008.• CorDx Ovulation Test strip, cassette and midstream are registered with HSA of Singapore.• This product has not been adverse events or FSCAs reported to date since the IVD medical device Pregnancy Test was first introduced on the global market.• Sensitivity: 25 mIU/ml. • Specificity: The test results show negative for 200 mlU/ml hFSH and 250 μlU/mL hTSH.• CorDx Ovulation Test strip, cassette and midstream are calibrated against reference material traceable to WHO International Standard 3rd edition.
Directions Allow the urine specimen to equilibrate to room temperature (15-30℃) prior to testing. Do not open pouch until ready to perform the test.1. Remove the test device from the sealed pouch and use it as soon as possible.2. Remove the Cap to expose the Absorbent Tip.3. Hold the test device by the Thumb Grip with the Absorbent Tip pointing downwards.4. Place the Absorbent Tip in direct urine stream for at least 5 seconds until it is thoroughly wet.5. Re-cap the test device and lay it on a flat surface with Result Window facing up.6. Read the test result between 3 to 10 minutes. Do not read result after 15 minutes.NOTE: Be careful do not urinate in the Result Window.
Cautionary Instructions 1. Reagents used in this test exhibit cross-reactivity with hCG. The purpose of this test is to analyse LH in specimens devoid of hCG.2. Elevated LH concentration may be observed in women who experience polycystic ovary syndrome.3. Pregnancy, menopause, hormone-containing treatment, steroids and contraceptives, etc. may affect the test result. Consult your doctor foryour ovulation test results.4. The test offers a preliminary diagnostic assessment of ovulation timing.5. It is crucial to seek guidance from the physician before making any significant medical decisions.6. Individuals with visual impairments such as color blindness or color deficiency may potentially misinterpret the test results.