6 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. 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 ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

FDA Enforcement
Class II ·Terminated·BioMerieux SA·March 29, 2017

URGO Protecteur Cors

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Laboratoires URGO HEALTHCARE·2 devices

Protecteur mousse cors

Basic UDI-DI
EU MDR · Eu Md Class 1 ·La Brosse et Dupont·1 device

URGO Traitement Cors & Oeils-de-perdrix

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Laboratoires URGO HEALTHCARE·1 device

PROCESS FOR PRF

Authorized representative
🇫🇷 France·1 Manufacturer

For Health Consulting

Authorized representative
🇫🇷 France