Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
CancerCheck ® fPSA
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06974404980036
- Basic UDI-DI Code
- B-06974404980036
- Reference
- K32-FPSA
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Additional Description
The CancerCheck® fPSA rapid test is a chromatographic immunoassay for the quantitative detection of free prostate-specific antigen in human serum or plasma. Free PSA in combination with PSA testing is a screening tool for early detection of prostate cancer. It is not automated and the testing population is adult male. This in vitro diagnostic rapid test is only for professional use in clinical units or doctor´s offices.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030114 | FREE PROSTATIC SPECIFIC ANTIGEN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 061788 0008 | TÜV SÜD Product Service GmbH | Expired |
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