Ureaplasma urealyticum Real-time PCR Kit

Trade name

Ureaplasma urealyticum Real-time PCR Kit

UDI-DI code

06974912093747

Basic UDI-DI

B-06974912093747

Reference / catalog number

ITSZ092001

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

This kit is intended for the in vitro qualitative detection of Ureaplasma urealyticum (UU) nucleic acid in male urethral samples and female cervical samples and for the auxiliary diagnosis of UU infection. Ureaplasma urealyticum is divided into two biogroups (ureaplasma micutus, ureaplasma urealyticum), a total of 14 serotypes, can cause urogenital tract infection, and is considered to be the second only to chlamydia in the cause of non-gonococcal urethritis. The complications were: nongonococcal urethritis, acute epididymitis, prostatitis, male infertility and female infertility. The commonly used detection methods include morphological examination, mycoplasma culture, antigen detection, serological test and molecular biology method.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W010501080303UREAPLASMA DETECTION BY NA REAGENTS

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  1. Disinfect the spilled samples and reagents. 2. In order to avoid possible contamination during the pipetting process, it is recommended to use a disposable pipette tip with a filter element and inject it into a waste liquid tank filled with 1% sodium hypochlorite after use. 3. The specimens to be tested must be treated as infectious items, and the operating procedures must follow laboratory safety procedures. Disinfection and disposal of various wastes and wastes must be carried out in accordance with local regulations.

No certificate specifically references this device's Basic UDI-DI.