Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇸🇬 Singapore
MP Diagnostics HCV ELISA 4.0
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08887581000504
- Basic UDI-DI Code
- B-08887581000504
- Reference
- 23130-480
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- MP Biomedicals Asia Pacific Pte Ltd
Additional Description
The MP Diagnostics HCV ELISA 4.0 is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to hepatitis C virus (HCV) in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis C virus.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020303 | HCV ANTIBODY (TOTAL) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | IVDD 21 062 0130 | bqs. s.r.o. | Expired |
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