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VIDASยฎ RUB IgG II - SFDA Registration ME0000001030SFDAA00241

Access comprehensive regulatory information for VIDASยฎ RUB IgG II 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 ME0000001030SFDAA00241 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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SFDA Official Data
Annex II List B
ME0000001030SFDAA00241
VIDASยฎ RUB IgG II
SFDA Registration: ME0000001030SFDAA00241
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Product Information

Detection of Immunoglobulins G (IgG)

Product Use

VIDAS RUB IgG II (RBG) is an automated quantitative test for use on the VIDAS family instruments, for the quantitative measurement of immunoglobulins G (IgG) directed against the Rubella virus in human serum or plasma (heparin or EDTA) 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
ME0000001030SFDAA00241
Authorization ID
GHTF-2019-2657
Status
Active
Expire Date
May 26, 2024
Manufacturer
Manufacturer Name
BIOMERIEUX S.A.
Model Information
Model ID(s)
30221
Product Accessories

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