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Liofilchem MTS (MIC Test Strip)

LIOFILCHEM SRL · Model Eravacycline ERV 0.002-32 µg/mL 1 STRIP · UDI-DI 08055182872893

JWY Prescription
1
510(k) clearances
153
Adverse events
78
Recalls
9
Facilities

Description

The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of incubation. MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria. Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label: Gram-positive bacteria Enterococcus faecalis Enterococcus faecium Staphylococcus aureus Gram-negative bacteria Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label: Citrobacter koseri Klebsiella (Enterobacter) aerogenes

Recalls

DateFirmReason
2025-05-01Remel, IncProduct may have an off color affecting perfomance
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.