Basic Information
- Primary DI
- 08719327450901
- Basic UDI-DI Code
- B-08719327450901
- Reference
- QQF-100
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- IQ Products BV
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010202 | HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1) |
Available In Countries
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