The MobiLab Standard Sexual Health Self Screening Kit (urine specimen) includes individual test cassettes for: 1. Trichomonas Vaginalis (TV) 2. Candida Albicans (Yeast) (CA) 3. Gardnerella…
The MobiLab Standard Sexual Health Self Screening Kit (urine specimen) includes individual test cassettes for: 1. Trichomonas Vaginalis (TV) 2. Candida Albicans (Yeast) (CA) 3. Gardnerella Vaginalis (GV) 4. Mycoplasma Genitalium (MG) 5. Chlamydia Trachomatis (CHT) 6. Neisseria Gonorrhoeae (NGH). 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.
Who Else Makes It
Concentrated in Jilin (5), Shandong (2).
Record
Regulatory record for MobiLab Standard Sexual Health Self Rapid Test | Listed by | MobiLab Medical Innovatives Inc. |
| FDA product code | JXA |
| Device type | Kit, Screening, Urine |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Premarket notification | Exempt |
| Record published | 2024-02-05 |
| Record revised | 2025-04-04 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-02-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.