Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
π¨π³ China
PSA - RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-CNM0000180729002NP
- Basic UDI-DI Code
- B-CNM0000180729002NP
- Reference
- 9002C
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Shanghai Chemtron Biotech Co., Ltd.
Additional Description
Prostate Specific Antigen Rapid Test is a rapid direct binding test for the detection of Prostate Specific Antigen (PSA) in serum or plasma, it is intended for professional use as an aid in the diagnosis of prostate cancer. The test is based on the principle of sandwich immunoassay for determination of PSA in serum or plasma. Monoclonal and polyclonal antibodies are employed to identify PSA specifically. This one step test is very sensitive and only takes about 5-8 minutes. The sensitivity of the test can reach to 4ng/ml.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160202 | PSA - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 076482 0004 | TΓV SΓD Product Service GmbH | Expired |
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