A58124

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 2 countries total.

Trade name

not provided

UDI-DI code

08595696304027

Basic UDI-DI

859569630025QH

Reference / catalog number

A58124

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. Neisseria gonorrhoeae infection can cause cervicitis in women and urethritis in men. In women, the infection can cause pelvic inflammatory disease, ectopic pregnancy and infertility. In men the infection can lead to epididymitis, urethral stricture and infertility. Infants of mothers with gonococcal infection can contract neonatal conjunctivitis, which may lead to blindness. The GeneProof Neisseria gonorrhoeae PCR Kit is an in vitro nucleic acid amplification test intended for detection of N. gonorrhoeae by real-time polymerase chain reaction (PCR) method. The clinical specimens used for the detection are sperm, swabs and urine. The GeneProof Neisseria gonorrhoeae 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 and aid to diagnosis, and it is designed for professional use in laboratories with trained staff.

Additional information URL

https://thermofisher.com/geneproofIFU

Clinical sizes

No clinical sizes registered for this device.

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