First FDA-Cleared Liofilchem MIC Test Strip: Vancomycin
Liofilchem has received clearance from the FDA to market the product Vancomycin MIC Test Strip in the United States. It is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of vancomycin against Staphylococcus aureus and Staphylococcus epidermidis (including methicillin resistant strains), Enterococcus faecalis and Enterococcus faecium.
MIC Test Strip are porous strips with special features (Italian Patent no. 1395483 and International Patent pending) that are impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions of a conventional M.I.C. method.
On one side of the strip is indicated a M.I.C. scale in μg/mL and a code that identify the antimicrobial agent.
Vancomycin MIC Test Strip 0.016 - 256 μg/mL 10 strip pack: ref. 920571 30 strip pack: ref. 92057 100 strip pack: ref. 920570
Vancomycin is the first of a long series of MIC Test Strip items to be soon approved by FDA. In the meanwhile, the rest of MIC Test Strip range is available in the United States as research use only devices, while the entire MIC Test Strip product catalog is CE marked and fully available as IVD for clinical diagnostics purposes in Europe and approved in Canada by Health Canada. MIC Test Strip is also registered at the competent Authority in many countries outside Europe as a clinical diagnostic.
The current MIC Test Strip range comprises antibiotics, antifungals, antimycobacterials, and combined strips for resistance mechanisms detection (ESBL, MBL, KPC, AmpC and GRD) for over 150 items, each available in three pack formats (10, 30 and 100), for the widest gradient strip range in the international market.
Date Published: 19th May 2016
Source article link: Liofilchem
Disc Tests for Confirmation of
FDA-Cleared Liofilchem MIC Test Strip