Coated Standardized Red Blood Cells to direct antiglobulin test control

Organization name

Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

SRN

PL-MF-000037642

Manufacturer status

Active

Primary placement in Poland; available across 1 country total.

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

Trade name

Coated Standardized Red Blood Cells to direct antiglobulin test control

UDI-DI code

05904365620093

Basic UDI-DI

B-05904365620093

Reference / catalog number

514

Issuing entity

GS1

Risk category

IVDD — Annex II List B

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Standardised Coated Reference Cells for BTA Control (SKWO-BTA) set contains the following preparations: • Standardised O RhD+ cells coated with anti-D antibodies (SKWO+), • Standardised O RhD+ cells coated with anti-D antibodies (SKWO-). The RBC count in the individual preparations is 0.92-1.15 million/µl (dilution of the cell suspension is 25% +/- 2%). Before use, SKWO-BTA set cells should be washed with buffered physiological saline solution pH 6.9 (PBS) and a 3-4% suspension made

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0103030401COOMBS CONTROL CELLS