FMH QuikQuant

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 9 countries total.

Trade name

FMH QuikQuant

UDI-DI code

08719327450901

Basic UDI-DI

B-08719327450901

Reference / catalog number

QQF-100

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 FMH QuikQuant™ 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 FMH QuikQuant™ is based on a sensitive and accurate, non-automated flow cytometric method, which offers a fluorescent detection of the intracellular antigen, fetal hemoglobin (HbF). HbF is detected in red blood cells obtained from EDTA anti-coagulated or heparin-treated human peripheral whole blood. The FMH QuikQuant™ is intended for use in hospital clinical and reference laboratories by trained medical technologists or similar individuals having experience in test methods for FMH and flow cytometry.

Additional information URL

https://www.iqproducts.nl/products/perinatal/fmh-quikquant/

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)