Organization name

IQ Products BV

SRN

NL-MF-000010812

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

Primary placement in Netherlands; available across 18 countries total.

Trade name

Fetal Cell Count Kit

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08717953022332

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-08717953022332

Reference / catalog number

IQP-363

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

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

• IVDD — General medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.