Eu Ivdd Eu Ivd Annex 2 List A On The Market 🇸🇬 Singapore

MP Diagnostics HIV Blot 2.2

MP Biomedicals Asia Pacific Pte Ltd · 🇸🇬 Singapore
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

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
IVDD Annex IV Section 4 V7 068207 0046

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