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Etestยฎ AZ Azithromycin - SFDA Registration ME0000001030SFDAA00133

Access comprehensive regulatory information for Etestยฎ AZ Azithromycin in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000001030SFDAA00133 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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General IVD(Others)
ME0000001030SFDAA00133
Etestยฎ AZ Azithromycin
SFDA Registration: ME0000001030SFDAA00133
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Product Information

Testing for Antimicrobial Susceptibility

Product Use

Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ฮผg/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001030SFDAA00133
Authorization ID
GHTF-2018-0621
Status
Active
Expire Date
September 14, 2021
Manufacturer
Manufacturer Name
BIOMERIEUX S.A.
Model Information
Model ID(s)
501618, 501608, 412257, 501600
Product Accessories

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