Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
CEA Fast Test Kit (Immunofluorescence Assay)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06954414702408
- Basic UDI-DI Code
- B-06954414702408
- Reference
- /
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Getein Biotech, Inc.
Additional Description
CEA Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of carcinoembryonic antigen (CEA) in serum or plasma samples. This test can be used as a tumor marker to monitor colorectal carcinoma treatment and follow-up. But CEA test is not reliable for diagnosing cancer or as a screening test for early detection of cancer. For professional and laboratory use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030112 | CARCINOEMBRYONIC ANTIGEN |
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