Milenia QuickLine HIT

Organization name

Milenia Biotec GmbH

SRN

DE-MF-000028733

Manufacturer status

Active

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

• CW999

  Do not interchange components of packages of different batch codes.
• CW132

  Material Safety Data Sheets are available on request (see also www.milenia-biotec.com).
• CW999

  All samples, used Test Units, pipettes, tips, and other contaminated material should be handled carefully and as potentially infectious.
• CW267

  Contains biological material of animal origin
• CW007

  Do not use if package is damaged and consult instructions for use
• CW010

  Consult instructions for use or consult electronic instructions for use
• CW266

  The reagents provided in these kits contain materials of human and/or animal origin. Whenever human blood product is required for the preparation of these reagents, approved methods are used to test the blood for the antibodies to HIV 1, HIV 2 and HCV, and for hepatitis B surface antigen, and results are found to be negative. However, no test method can offer complete assurance that infectious agents are absent. Therefore, users of reagents of these types must exercise extreme care in full compliance with safety precautions in the manipulation of these biological materials as if they were infectious.

Primary placement in Germany; available across 1 country total.

Trade name

Milenia QuickLine HIT

UDI-DI code

04260177041206

Basic UDI-DI

B-04260177041206

Reference / catalog number

01059

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 STic Expert HIT is an in-vitro diagnostic lateral flow assay (kit) for the qualitative detection of human IgG antibodies against PF-4/polyanion complexes in citrated plasma or serum. The test is used to rule out HIT II (heparin-induced thrombocytopenia, type II) with a high degree of certainty in adult patients who have previously been treated with heparin and have an abnormal 4T score. The analysis is carried out exclusively by laboratory personnel indoors and was not developed for near-patient or self-use. The STic Expert HIT is evaluated manually (directly by the user using an evaluation card).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0103020402PLATELET FACTOR 4

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