3.150.XXX.YY.ZZZ

Organization name

OPERON, S.A.

SRN

ES-MF-000004790

Manufacturer status

Active

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

• CW265

  The denaturation solution contains < 2% NaOH

Primary placement in Spain; available across 9 countries total.

Trade name

not provided

UDI-DI code

D-84295773150WKFD

Basic UDI-DI

B-84295773150WKFD

Reference / catalog number

3.150.XXX.YY.ZZZ

Issuing entity

EUDAMED

Risk category

IVDD — Annex II List B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The STD Panel Strip test is a test based on the reverse blot technique that allows the qualitative detection of 10 pathogens associated to sexually transmitted diseases: Chlamydia trachomatis (discriminating variants L1, L2 and L3, that cause lymphogranuloma venereum), Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis, Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis, Herpes simplex 1, Herpes simplex 2,and Treponema pallidum. Through comparative analysis of described sequences using BLAST and BioEdit software the detection of all different serotypes/genetic sequences described for all the pathogens has been verified. So, all Chlamydia trachomatis serotypes (A, B, Ba, C, D, Da, E, F, G, H, I, Ia, J, Ja, K, L1, L2 y L3) and Ureaplasma spp serovars (1-14) are detected. The product may be used for any indication that involves the identification of the previously mentioned pathogens: initial diagnosis, screening, monitoring. Take also under consideration other parameters such as symptoms or clinical history when giving the final diagnosis.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W0105070501STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS

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