Chlamydia trachomatis

Organization name

Clonit srl

SRN

IT-MF-000022196

Manufacturer status

Active

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Trade name

Chlamydia trachomatis

UDI-DI code

08057680910220

Basic UDI-DI

B-08057680910220

Reference / catalog number

RT-22

Issuing entity

GS1

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 Chlamydia Trachomatis is a qualitative assay based on nucleic acids amplification for the identification of the Chlamydia Trachomatis (genomic regions cysteine-rich outer membrane protein and dnaB-like plasmidic gene of Chlamydia trachomatis genome, including Swedish variant) in samples of DNA extracted from Vaginal, Cervical, Uretral swab and Urine from individuals with an increased risk for infection of sexually transmitted pathogens. The device is intended for detecting the presence of, or exposure to, a sexually transmitted agent. This kit is for in vitro diagnostics (IVD), for professional use only and not for in vivo use."

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0105010117CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS