Standard anti-D (10x2ml)

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

Standard anti-D (10x2ml)

UDI-DI code

05904365620154

Basic UDI-DI

B-05904365620154

Reference / catalog number

109/10

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 Standard anti-D is a reagent prepared from plasma from immunised blood donors. It contains anti-D class IgG antibodies at a standardised concentration according to the recommendations of the EU and the Institute of Haematology and Transfusiology in Warsaw, no higher than 0.02 µg/ml (0.1 IU/ml). Correctly visible anti-D antibody reactions with ORhD+ reference cells, and negative reactions with ORhD- cells, provide a check on the correctness of the anti-globulin test and enzyme test.

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.

• W0103030499IMMUNOHAEMATOLOGY CONTROLS - OTHER