69501

Organization name

BAG Diagnostics GmbH

SRN

DE-MF-000024383

Manufacturer status

Active

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• CW010

  -

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04260224894205

Basic UDI-DI

426022489ELUK01AAKX

Reference / catalog number

69501

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

1

Additional product description

The intended purpose of the BAG-Elutions-Kit is to dissociate antibodies that are adsorbed onto red blood cells, either in vivo or in vitro, in an elution process to make the antibodies available for in vitro diagnostic examinations. These antibodies can then be detected and identified in a separate procedure using an in-vitro-diagnostic medical device.

Additional information URL

https://www.bag-diagnostics.com/

Clinical sizes

No clinical sizes registered for this device.

• W01030399IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER

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

This device is not currently linked to any other device.