Convenient 3IN1 vaginitis tester (medical device),Korean womens products

Permission, certification, report number Suheo No. 18-344/Ad preliminary review completed 2019-l 10-34-2627 Country of manufacture china Purpose and method of use of the product 1. Collect an appropriate amount (~5ml) of urine in the provided urine cup or disposable paper cup or glass cup.2. Open the purple cap of the eluent tube.3. Suck up 0.5ml of urine (up to the neck of the dropper or the line marked 0.5) with a dropper and transfer it all to the tube containing the developing solution. 4. Replace the cap of the developing solution tube and mix the contents by turning the tube clockwise for 5 seconds. 5. Open the pouch, take out the test card and place it on a flat surface.6. Open the small transparent cap at the top of the tube by turning it counterclockwise. 7. Drop 3 to 4 drops into the S region of each panel (TV, CA, GV) at the bottom of the test card. 8. After 15 minutes, read the results visually through the result reading window. Precautions for handling 1. This product is an in vitro diagnostic medical device and should be used only for in vitro diagnostic purposes. 2. This product is disposable and must not be reused. Products that have been used once must be discarded. 3. This product allows users with vaginitis symptoms to simultaneously determine whether they are infected with Trichomonas vaginalis, Candida albicans, and Gardnerella vaginalis, the three main causative microorganisms of vaginitis, using vaginal secretion and urine samples. 4. Before using and inspecting the product, be sure to read the product user manual. 5. Sealed products should be stored in a dry place at room temperature and away from direct sunlight. (Avoid excessive heat and do not store in the freezer.) 6. Do not use products past their expiration date. 7. Do not use if any damage is found on the sealed pouch. 8. Place the product as far away from children as possible. 9. It is recommended that you use the pouch containing the test card immediately after opening it, and discard the product 1 hour after opening. 10. When using urine as a sample, pay attention to the following points. ① It is recommended to use the first urine of the day. ② Hematuria is not recommended as a sample. ③ When mixing the developing solution and urine, mix so vigorously that foam occurs. Avoid mixing. If bubbles appear, wait 3 to 5 minutes until the bubbles disappear and then proceed with the test.11. Follow medical and laboratory safety guidelines for specimen collection, processing, storage, disposal, and all objects exposed to specimens.12. The developing solution is a neutral saline solution that contains low concentrations of sodium azide (antibacterial agent) and surfactant. If the developing solution comes in contact with your eyes or skin, wash it off with plenty of tap water for 1 to 2 minutes.13. Eluents containing sodium azide can react with lead or copper-based piping to form potentially explosive metal azide. When pouring the developing solution into the drain pipe, be sure to use a sufficient amount of water.14. Results read 15 minutes before or 30 minutes after dropping the sample on the card may not be accurate.15. A negative or positive result does not completely exclude or confirm the possibility of microbial infection, and additional testing and medical evaluation through a visit may be necessary.