ClinChek® Hemoglobin Control, lyophil., Level I, II, III, with Reconstitution Solution R

Organization name

RECIPE Chemicals + Instruments GmbH

SRN

DE-MF-000032553

Manufacturer status

Active

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• CW018

  See SDS Section 2

Primary placement in Germany; available across 32 countries total.

Trade name

ClinChek® Hemoglobin Control, lyophil., Level I, II, III, with Reconstitution Solution R

UDI-DI code

D-8816CE

Basic UDI-DI

B-8816CE

Reference / catalog number

8816

Issuing entity

EUDAMED

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

ClinChek® Controls are used for internal quality assurance in clinical-chemical laboratories. These lyophilised controls are based on human erythrocytes and are available with mean values in three different ranges of concentration. After reconstitution the controls have to be prepared like patient samples in one series of analyses. ClinChek® Hemoglobin Control 8816 consist of: - ClinChek® Control Level I, 8812; - ClinChek® Control Level II, 8813; - ClinChek® Control Level III, 8814

Additional information URL

https://recipe.de/myrecipe

Clinical sizes

No clinical sizes registered for this device.

• W0101050199MULTICOMPONENT CONTROLS (CC) - OTHER

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