Fetal Cell Count Kit

Organization name

IQ Products BV

SRN

NL-MF-000010812

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 18 countries total.

Trade name

Fetal Cell Count Kit

UDI-DI code

08717953022332

Basic UDI-DI

B-08717953022332

Reference / catalog number

IQP-363

Issuing entity

GS1

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

The Fetal Cell Count™ Kit is intended for the discrimination and quantitative detection of human fetal red blood cells (fRBC) in maternal blood. This method used for diagnosis of Fetomaternal Hemorrhage (FMH) is applied to peripheral blood samples of pregnant women with abdominal trauma and/or suspected Rhesus D (RhD) incompatibility. The Fetal Cell Count™ Kit is based on a sensitive and accurate, non-automated flow cytometric method, which offers a dual fluorescent detection of two intracellular antigens, fetal hemoglobin (HbF) and carbonic anhydrase (CA). Both HbF and CA are detected in red blood cells obtained from EDTA anti-coagulated or heparin-treated human peripheral whole blood. The complete dual-color staining and analysis of up to 5 samples, that must be executed and interpreted by well-trained and authorized laboratory technicians, can be concluded within 90 minutes from blood collection.

Additional information URL

https://www.iqproducts.nl/products/perinatal/fetal-cell-count-kit-diagnosis-of-fetomaternal-hemorrhage/

Clinical sizes

No clinical sizes registered for this device.

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• Expiration date
• Manufacturing date
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• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0103010202HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)