H3/5-CAL calibrator for Hemolyzer® hematology analyzers

Organization name

NORMA Instruments Zártkörűen Működő Részvénytársaság

SRN

HU-MF-000014244

Manufacturer status

Active

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• 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.

Primary placement in Hungary; available across 1 country total.

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

Trade name

H3/5-CAL calibrator for Hemolyzer® hematology analyzers

UDI-DI code

05999106200573

Basic UDI-DI

59991062NormaCalZ8

Reference / catalog number

HE3611

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

H3/5-Cal is intended for the calibration of Analyticon hematology analyzers Hemolyzer® 3 NG (HE3100) and Hemolyzer® 5 NG (closed and open mode) (HE5100 and HE5200).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0103010507WHOLE BLOOD CALIBRATORS

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