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VIDASยฎ CMV IgM - SFDA Registration ME0000001030SFDAA00234

Access comprehensive regulatory information for VIDASยฎ CMV IgM in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List B device is registered with Saudi Arabia SFDA under registration number ME0000001030SFDAA00234 and manufactured by BIOMERIEUX S.A..

This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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Annex II List B
ME0000001030SFDAA00234
VIDASยฎ CMV IgM
SFDA Registration: ME0000001030SFDAA00234
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Product Information

Detection of anti-cytomegalovirus IgM

Product Use

VIDAS CMV IgM is an automated qualitative enzyme immunoassay for use on the VIDAS family instruments, for the detection of anti-cytomegalovirus IgM (CMVM) in human serum, using the ELFA technique (Enzyme Linked Fluorescent Assay).

Device Classification
Risk Class
Annex II List B
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001030SFDAA00234
Authorization ID
GHTF-2014-0147
Status
Active
Expire Date
November 07, 2016
Manufacturer
Manufacturer Name
BIOMERIEUX S.A.
Model Information
Model ID(s)
30205
Product Accessories

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