SET OF CONTROL SAMPLES I – SCS I

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

SET OF CONTROL SAMPLES I – SCS I

UDI-DI code

05904365620130

Basic UDI-DI

B-05904365620130

Reference / catalog number

931

Issuing entity

GS1

Risk category

IVDD — Annex II List A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Control Sample Set consists of two "patient sample" test tubes each containing 5 ml of red cell and plasma suspension (haematocrit 15% +/-2%): • Control Sample 1 931-K1 - Group A RhD- dccee K -, • Control Sample 2 931-K2 - Group B RhD+ DCcEe K+.

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.

• W0103030402CONTROL KITS (IMMUNOHAEMATOLOGY)