CloNext Bacterial DNA Extraction Kit

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

CloNext Bacterial DNA Extraction Kit

UDI-DI code

08057680910732

Basic UDI-DI

805768091CNextBact_012Q

Reference / catalog number

OP02006-48

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

CloNext Bacterial DNA Extraction Kit, in association with the CloNext Automatic Extraction Systems, allows to extract and purify bacterial nucleic acids from human biological specimens, inactivation of pathogenic microorganism, bacterial pellet/colony from culture, clinical swab samples in liquid transport media, environment material (water, soil) for downstream in vitro diagnostic purposes. As an accessory for an in vitro diagnostic medical device it is intended to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable them to be used in accordance with their intended purpose(s). This kit is for professional use only.

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.

• W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS