STic Expert HIT Control

Organization name

Milenia Biotec GmbH

SRN

DE-MF-000028733

Manufacturer status

Active

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

• CW010

  Read this instruction manual and the instruction manual of Milenia QuickLine HIT test (REF MQHIT 1) carefully before performing the assay
• CW132

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

STic Expert HIT Control

UDI-DI code

04260177041152

Basic UDI-DI

B-04260177041152

Reference / catalog number

MQCOHIT 1

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Milenia QuickLine HIT Control/STic Expert HIT Control is used for quality control for the corresponding Milenia QuickLine HIT/STic Expert HIT test. The HIT control includes a negative and a positive sample. It is used to determine test validity. The tests are carried out indoors exclusively by laboratory staff

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W010302080501HEMOSTASIS CONTROLS RT & POC

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