Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
Prostate Specific Antigen (PSA) Diagnostic Kit
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06971348760106
- Basic UDI-DI Code
- B-06971348760106
- Reference
- MF-46-20
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Shenzhen Microprofit Biotech Co., Ltd.
Additional Description
The PSA is applicable to the quantitative detection of the concentration of PSA in human serum or plasma. A number of studies have proved that serum and plasma PSA levels can predict prostate cancer. For patients with prostate cancer after surgery or treatment, abnormal PSA levels can predict recurrence or other residual diseases. PSA testing has been widely used as an aid to the management of prostate cancer patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030113 | TOTAL PROSTATIC SPECIFIC ANTIGEN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 109172 0002 Rev. 00 | TÜV SÜD Product Service GmbH | Expired |
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