Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USE

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 ORhD+ with anti-D antibodies READY TO USE

UDI-DI code

05904365620116

Basic UDI-DI

B-05904365620116

Reference / catalog number

915

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

Standardised Reference Cells ORhD+ coated with anti-D antibodies (STKWO+) are a product intended for direct use in in-vitro immunohaematology tests performed by test tube technique. The product consists of a suspension of O RhD+ phenotype reference cells (haematocrit approximately 1,33%) coated with a standardised amount of anti-D class IgG antibodies.

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