MQHIT 1

Organization name

Milenia Biotec GmbH

SRN

DE-MF-000028733

Manufacturer status

Active

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

• 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.

Placed on the market in Germany; per-country availability dates not published.

Trade name

not provided

UDI-DI code

04260177041305

Basic UDI-DI

B-04260177041305

Reference / catalog number

MQHIT 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

Lateral Flow Immunoassay to detect IgG antibodies against PF4/polyanion-complexes

Additional information URL

https://www.milenia-biotec.com/en/product/hit-20-tests/

Clinical sizes

No clinical sizes registered for this device.

• W0103020402PLATELET FACTOR 4

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