quanty TOXO (RH Region)

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

quanty TOXO (RH Region)

UDI-DI code

08057680910275

Basic UDI-DI

B-08057680910275

Reference / catalog number

RT-94

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 quanty Toxo is a quantitative assay based on nucleic acids amplification for the identification and the quantification of a 529-bp repeat region of Toxoplasma gondii (Toxo) in samples of DNA extracted from whole peripheral blood collected in EDTA and Amniotic fluid from pregnant women and immunocompromised individuals. The device is intended for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual's offspring. 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.

• W0105050105TOXOPLASMA - NA REAGENTS