Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
π¨π³ China
HEPATITIS B VIRUS - NA REAGENTS
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 06928103000410
- Basic UDI-DI Code
- B-06928103000410
- Reference
- DA0041
- 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 intended for the quantitative detection of HBV DNA in human serum or plasma specimen. The test result is for clinical reference only and should not be used as a sole basis for definite diagnosis or exclusion of infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020216 | HEPATITIS B VIRUS - NA REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CeCert/045/W/E.1 | CeCert Sp. z o.o. | Expired |
| IVDD Annex IV Section 4 | CeCert/044/W/E.1 | CeCert Sp. z o.o. | Expired |
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