Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇸🇬 Singapore
MP Diagnostics HIV Ag/Ab Combo ELISA 4.0
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08887581002133
- Basic UDI-DI Code
- B-08887581002133
- Reference
- 23040-480
- 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
MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 is an enzyme-linked immunosorbent assay (ELISA) intended for qualitative detection of antigens and/or antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M - O) and/or type 2 in human serum or plasma specimens. The method is also known as 4th generation ELISA for HIV detection. The kit is intended for screening of blood donors and as an aid in the diagnosis of clinical conditions related to infection with HIV-1 and/or HIV-2 - the etiological agents of the acquired immunodeficiency syndrome (AIDS).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105030404 | HIV MULTIPLE AG/AB COMBI TEST |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | IVDD 21 060 0126 | bqs. s.r.o. | Expired |
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