MGH/GP/100

Organization name

GeneProof a.s.

SRN

CZ-MF-000002370

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 7 countries total.

Trade name

not provided

UDI-DI code

08595696300326

Basic UDI-DI

859569630010Q4

Reference / catalog number

MGH/GP/100

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The intended purpose of the device is related to the medical context and clinical conditions under which the device may be used. Mycoplasma genitalium and Mycoplasma hominis infection can cause dysuria, inter-menstrual or post-coital bleeding, cervicitis, pelvic inflammatory disease, ectopic pregnancy, pre-term delivery or infertility in women. In men, infection can cause urethritis, dysuria, urethral discharge, proctitis, reactive arthritis or epididymitis. The GeneProof Mycoplasma genitalium/hominis PCR Kit is an in vitro nucleic acid amplification test intended for detection of Mycoplasma genitalium and Mycoplasma hominis by real-time polymerase chain reaction (PCR) method. The clinical specimens used for the detection are swabs and urine. The GeneProof Mycoplasma genitalium/hominis PCR kit can be used in combination with a manual or automated extraction system. The kit is designed for human in vitro diagnostics and provides qualitative detection. The kit is intended for diagnostics, an aid to diagnosis and it is designed for professional use in laboratories with trained staff.

Additional information URL

https://www.geneproof.com/ifu

Clinical sizes

No clinical sizes registered for this device.

• W010501080302UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS

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