Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇸🇬 Singapore
MP Diagnostics HBsAg ELISA 4.1
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08887581001006
- Basic UDI-DI Code
- B-08887581001006
- Reference
- 23470-480
- 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 HBsAg ELISA 4.1 is an enzyme-linked immunosorbent assay (ELISA) intended for qualitative detection of HBsAg in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis B virus.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090201 | HBSAG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | IVDD 21 061 0128 | bqs. s.r.o. | Expired |
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