H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials

Organization name

NORMA Instruments Zártkörűen Működő Részvénytársaság

SRN

HU-MF-000014244

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW008

  All body fluid samples should be considered potentially infectious materials. The product was tested negative against anti-HIV 1 and 2, antiHCV and HBsAg, but since no test method can rule out the danger of infection with absolute certainty, treat all blood and other potentially infectious materials with appropriate precautions. Use gloves, masks and gowns if blood exposure is anticipated.
• CW011

  For in vitro diagnostic use only. For trained laboratory professional only.

Primary placement in Hungary; available across 1 country total.

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

Trade name

H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials

UDI-DI code

05999106200559

Basic UDI-DI

59991062NormaCont56F

Reference / catalog number

HE5504

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

H5-Check Control Sets are intended for quality control measurements on Analyticon hematology analyzers Hemolyzer® 5 NG (open and closed mode) (HE5100 and HE5200), and serve to validate the measurement results.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0103010503MULTILEVEL BLOOD CONTROLS

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• Expiration date
• Manufacturing date
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