SPEC.SYSTEM 301201+308202 CAPP

Organization name

Deltalab, S.L.

SRN

ES-MF-000000153

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  • Not suitable for any application other than its intended use. • Do not squeeze or press the container. • Do not use if the product or any of its components is damaged. • Do not re-use. The re-use of this product may affect the subsequent analysis of the sample taken.
• CW011

  Healthcare professionals must validate the use of the container for their specific assay instrument/reagent system combinations and specimen storage conditions.

Primary placement in Spain; available across 1 country total.

Trade name

SPEC.SYSTEM 301201+308202 CAPP

UDI-DI code

08435263839951

Basic UDI-DI

84356058UDI-DI-2268

Reference / catalog number

309324.PS

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

300

Additional product description

Urine sample collection kits consist mainly of a natural polystyrene cup with a total capacity of 120 ml (without a lid) and a labelled tube with an airtight cap, individually packaged with printed instructions for use, including the batch number and expiry date.

Additional information URL

https://www.deltalabgroup.com/eifus

Clinical sizes

No clinical sizes registered for this device.

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

• W05010203URINE COLLECTION, CONTAINERS

Certificate health across this manufacturer's portfolio.