Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇸🇬 Singapore
MP Diagnostics HIV Blot 2.2
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08887581000092
- Basic UDI-DI Code
- B-08887581000092
- Reference
- 11030-018
- Device Types
-
Single use
- 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 HIV Blot 2.2 is a qualitative enzyme immunoassay for the in vitro detection of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) in human serum or plasma. It is intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using screening procedures such as the Enzyme-Linked Immunosorbent Assay (ELISA).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105030403 | HIV MULTIPLE ANTIBODY - CONFIRMATORY |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | V7 068207 0046 | TÜV SÜD Product Service GmbH | Expired |
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