Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
π¨π³ China
HEPATITIS C VIRUS - NA REAGENTS
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 06928103001820
- Basic UDI-DI Code
- B-06928103001820
- Reference
- DA0182
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- Daan Gene Co., Ltd.
Additional Description
This kit is used for the quantitative detection of hepatitis C virus (HCV) RNA in human serum or plasma specimens. The test results of this kit are for clinical reference only and cannot be used solely as the basis for diagnosis or exclusion of cases. This kit is not intended for use as a screening test for the presence of HCV in blood or blood products.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020307 | HEPATITIS C VIRUS - NA REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CeCert/043/W/E.1 | CeCert Sp. z o.o. | Expired |
| IVDD Annex IV Section 4 | CeCert/042/W/E.1 | CeCert Sp. z o.o. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).
Multiple Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market