Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260207138
- Basic UDI-DI Code
- B-06933260207138
- Reference
- BT0505602
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
It is used for in vitro quantitative detection of the Alpha-fetoprotein (AFP) concentration in human serum, plasma that contains heparin /EDTA and other anticoagulants and venous whole blood samples, mainly used for auxiliary diagnosis of non-spermatogonium embryonic cell tumor and with other parameters assess the risk of trisomy 21 (Downsyndrome).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102039001 | ALPHAFETOPROTEIN |
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