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Surearly SMART

Surearly SMART (SSMD001E) · Sugentech Inc._Osong Branch

Surearly SMART is a self-testing in-vitro diagnostic device that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc. in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the Surearly SMART App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed.

Details

Device typePhotometric/spectroscopic immunoassay analyser IVD: An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory.

FDA categoryTest, Follicle Stimulating Hormone (Fsh), Over The Counter, Test, Luteinizing Hormone (Lh), Over The Counter

Device ID08809408863499

AvailabilityOver the counter

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone1-800-526-0943

Emailinfo@sugentech.com

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