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Know Rapid STD Test

MobiLab Medical Innovatives Inc. · Model MSSH · UDI-DI 00860008737359

510(k) clearances

Adverse events

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Description

The Know Rapid STD Screening Kit (Urine Test Cassette) includes individual test cassettes for: 1. Chlamydia Trachomatis (CHT) 2. Neisseria Gonorrhoeae (NGH) 3. Trichomonas Vaginalis (TV) 4. Mycoplasma Genitalium (MG). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.