Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
Free Prostate Specific Antigen Assay kit
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06954376012362
- Basic UDI-DI Code
- B-06954376012362
- Reference
- 69543760F000045Z
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Beijing Leadman Biochemistry Co., Ltd.
Additional Description
The F-PSA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of F-PSA in human serum.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030114 | FREE PROSTATIC SPECIFIC ANTIGEN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 071450 0018 | TÜV SÜD Product Service GmbH | Expired |
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