Fetal Cell Count Kit
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Basic Information
- Primary DI
- 08717953022332
- Basic UDI-DI Code
- B-08717953022332
- Reference
- IQP-363
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- IQ Products BV
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010202 | HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 2114921 | DEKRA Certification B.V. | Expired |
Available In Countries
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