MQHM Z

Organization name

Milenia Biotec GmbH

SRN

DE-MF-000028733

Manufacturer status

Active

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

• 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.
• CW010

  Read these instructions for use carefully before performing the test. Follow them step by step
• CW267

  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.
• CW007

  Do not use Test Unit if foil pouch is damaged.
• CW132

  Material Safety Data Sheets are available on request (look as well www.milenia-biotec.de).

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260177043002

Basic UDI-DI

B-04260177043002

Reference / catalog number

MQHM Z

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 HAMA is an in-vitro diagnostic lateral flow immunoassay for the qualitative detection of human anti-mouse IgG antibodies in human serum. The test is used in adult patients with suspected human anti-mouse IgG antibodies due to previous exposure to mouse antibodies (IgG). The analysis is performed indoors by laboratory personnel only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102010113HUMAN ANTI-MOUSE ANTIBODY

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