Saudi Arabia SFDA registration ME0000001030SFDAA00135
Etest® XL Amoxicillin*/Clav 2/1
Saudi Arabia·Chemicals·BIOMERIEUX S.A.·General IVD(Others)ActiveProduct 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 μg/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
- ME0000001030SFDAA00135
- Authorization ID
- GHTF-2018-0621
- Status
- Active
- Expire Date
- September 14, 2021
Manufacturer
- Manufacturer Name
- BIOMERIEUX S.A.
Model information
- Model ID(s)
- 501018, 412241, 501000
Product accessories
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About this record
Access comprehensive regulatory information for Etest® XL Amoxicillin*/Clav 2/1 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 ME0000001030SFDAA00135 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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