Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
PSA Rapid Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06974404980494
- Basic UDI-DI Code
- B-06974404980494
- Reference
- 811002
- 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 PSA Rapid Test is a chromatographic immunoassay for the quantitative detection of total prostate-specific antigen (PSA) in human serum or plasma. 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 |
|---|---|
| W0102030113 | TOTAL PROSTATIC SPECIFIC ANTIGEN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 061788 0008 | TÜV SÜD Product Service GmbH | Expired |
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