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FDA-Cleared Liofilch...

FDA-Cleared Liofilchem MIC Test Strip (MTS™) Linezolid (LNZ)


Liofilchem has received clearance from the FDA to market in the United States the Linezolid (LNZ) MIC Test Strip (MTS™), a quantitative assay for determining the Minimum Inhibitory Concentration (MIC) of linezolid against Staphylococcus aureus (including methicillin-resistant isolates) and Enterococcus faecium (vancomycin resistant isolates only).

More technical details on the Linezolid MIC Test Strip IFU

MIC Test Strips (MTS™) are porous strips with special features (International Pate MIC nt) that are impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions of a conventional MIC method. On one side of the strip there is a printed MIC scale in μg/mL and a code that identifies the antimicrobial agent.

MIC Test Strip Linezolid 0.016-256 μg/mL

    • 10 strip pack: ref. 921351
    • 30 strip pack: ref. 92135
    • 100 strip pack: ref. 921350

Linezolid is the most recent FDA approved item in the MIC Test Strip product range, following approvals of Meropenem-vaborbactam, Vancomycin, Dalbavancin, Ceftolozane-tazobactam, Meropenem, Ceftazidime, Telavancin, Tedizolid, Delafloxacin, Clindamycin and Erythromycin strips.

In the meantime, the rest of the 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 device.

The current MIC Test Strip range comprises antibiotics, antifungals, antimycobacterials, and combined strips for detection of resistance mechanisms (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.


      

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Date Published: 15th May 2018

Source article link: Liofilchem s.r.l.


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