Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
tPSA Rapid Quantitative Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260208623
- Basic UDI-DI Code
- B-06933260208623
- Reference
- BT2404
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
The Biotime tPSA Rapid Quantitative Test is intended to quantify the concentration of tPSA(Prostate Specific Antigen) in human serum on Biotime FIA Analyzer by fluorescent immunoassay. The test is used as an aid detection of prostate diseases including prostate cancer.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
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