21004D

Organization name

Thermo Fisher Scientific Baltics UAB

SRN

LT-MF-000046574

Manufacturer status

Active

Primary placement in Lithuania; available across 1 country total.

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

Trade name

not provided

UDI-DI code

10190302006828

Basic UDI-DI

B-10190302006828

Reference / catalog number

21004D

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

Dynabeads™ HLA Class II is designed for rapid isolation HLA Class II+ cells (B lymphocytes) directly from peripheral blood. The isolated cells can be used directly in microcytotoxic HLA Class II (DR, DQ, and DP) assays. Device is intended for professional use. The users are laboratories performing microcytotoxic assays: • Bone Marrow Registries • Donor Selection (solid organ & bone marrow) • Research Uses • Laboratories performing high throughput typing.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01030405LYMPHOCYTE SEPARATION MEDIA