US FDA-cleared MTS™ (MIC Test Strip)

The following materials are valid only for users based in the United States or subjected to the US FDA regulations on in-vitro diagnostics (IVD) devices. Users based in countries other than the US may refer to MTS™ materials listed at www.liofilchem.com/MTS

e-IFU latest revision 510(k) Substantial Equivalence Determination
Decision Summary
MTS™ Piperacillin-tazobactam rev.1 - 19/04/2022
MTS™ Lefamulin rev.0 - 06/04/2020
MTS™ Ampicillin-sulbactam rev.0 - 06/12/2019
MTS™ Imipenem rev.1 - 19/04/2022
MTS™ Imipenem-relebactam rev.1.1 - 31/07/2020
MTS™ Doxycycline rev.1 - 19/04/2022
MTS™ Gentamicin rev.1 - 19/04/2022
MTS™ Ciprofloxacin rev.2 - 19/04/2022
MTS™ Levofloxacin rev.2 - 19/04/2022
MTS™ Tetracycline rev.0.1 - 01/09/2020
MTS™ Omadacycline rev.2 - 19/04/2022
MTS™ Eravacycline rev.0 - 02/11/2018
MTS™ Penicillin G rev.1 - 19/04/2022
MTS™ Plazomicin rev.0 - 31/07/2018
MTS™ Delafloxacin rev.1 - 29/06/2018
MTS™ Azithromycin rev.0 - 29/05/2018
MTS™ Meropenem rev.3 - 19/04/2022
MTS™ Tedizolid rev.2 - 23/10/2017
MTS™ Erythromycin rev.0.1 - 31/01/2020
MTS™ Clindamycin rev.1 - 19/04/2022
MTS™ Meropenem-vaborbactam rev.2 - 19/04/2022
MTS™ Ceftazidime-avibactam rev.1 - 19/04/2022
MTS™ Linezolid rev.0.1 - 11/05/2018
MTS™ Telavancin rev.1 - 30/08/2017
MTS™ Ceftazidime rev.2 - 19/04/2022
MTS™ Ceftolozane-tazobactam rev.4 - 19/04/2022
MTS™ Dalbavancin rev.2 - 19/04/2022
MTS™ Vancomycin rev.3 - 19/04/2022
Lot specific e-IFU

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