Basic Information
- Primary DI
- 08436610290272
- Basic UDI-DI Code
- 843661029ML0010153
- Reference
- ML001
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Vircell, S.L
Additional Description
Nucleic acid amplification test for the simultaneous detection of nucleic acids from the following microorganisms: Chlamydia trachomatis (CTR) and Neisseria gonorrhoeae (NGO) in human pharyngeal swabs, vaginal/endocervical swabs, urethral swabs, rectal swabs and urine. Trichomonas vaginalis (TVA) in human vaginal/endocervical swabs. Mycoplasma genitalium (MGE) and 23S rRNA macrolide resistance-associated mutations at A2059 (59mut) and A2058 (58mut) in human vaginal/endocervical swabs, urethral swabs, rectal swabs and urine. Ureaplasma urealyticum (URE), Ureaplasma parvum (UPA), Mycoplasma hominis (MHO) in human vaginal/endocervical swabs, urethral swabs and urine. CTR serovar L (LGV) in human ulcer specimens and rectal swabs. Herpes simplex virus type 1 (HSV1), Herpes simplex virus type 2 (HSV2), Treponema pallidum (TPA), Haemophilus ducreyi (HDU) and Monkeypox virus (MPXV) in human ulcer specimens. The device is intended to be used with general population with suspected infection by the microorganism. The test is a qualitative and automated assay, intended to be used as an aid to diagnosis.
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] |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).