14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR)
Basic Information
- Primary DI
- D-000012807174097QV
- Basic UDI-DI Code
- B-000012807174097QV
- Reference
- HWTS-UR040
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Additional Description
The kit is intended for the in vitro qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma hominis (Mh), Herpes simplex virus type 1 (HSV1), Ureaplasma urealyticum (UU), Herpes simplex virus type 2 (HSV2), Ureaplasma parvum (UP), Mycoplasma genitalium (Mg), Candida albicans (CA), Gardnerella vaginalis (GV), Trichomonal vaginitis (TV), Group B streptococci (GBS), Haemophilus ducreyi (HD), and Treponema pallidum (TP) in urine, male urethral swab, female cervical swab, and female vaginal swab samples, and provide aid to the diagnosis and treatment of patients with genitourinary tract infections.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070501 | STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01] |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).