Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
CHROMOSOMAL DISORDERS TESTS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975358885514
- Basic UDI-DI Code
- B-06975358885514
- Reference
- 04110012
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biofast Biotechnology Co., Ltd.
Additional Description
This kit is used for in vitro quantitative diagnosis of the autosome (chromosome 1-22) and sex chromosomes associated with pregnancy loss : trisomy,triploidy and monosomy X . The test utilizes amplification human genomic DNA purified from chorionic villus tissue by multiplex Polymerase Chain Reaction and separated by capillary electrophoresis to precisely determine the shot tandem repeat markers that are located on the chromosomes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010399 | CHROMOSOMAL DISORDERS TESTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries