Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
iFlash-Total PSA
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C86000W3
- Basic UDI-DI Code
- B-C86000W3
- Reference
- C86000
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- SHENZHEN YHLO BIOTECH CO., LTD.
Additional Description
The iFlash-Total PSA assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for the quantitative determination of total prostate specific antigen (TPSA) in human serum and plasma using the iFlash Immunoassay Analyzer. The iFlash-Total PSA mainly aids in dynamic monitoring of malignant tumor process or treatment. The measurement results should not be used in the early detection and diagnosis for malignant tumor or tumor screening.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030113 | TOTAL PROSTATIC SPECIFIC ANTIGEN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 101298 0002 | TÜV SÜD Product Service GmbH | Expired |
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