FDA Device Intelligence
HomeLIOFILCHEM SRL › Liofilchem Mic Test Strip (MTS)

Liofilchem Mic Test Strip (MTS)

LIOFILCHEM SRL · Model Tetracycline TE 0.016-256 µg/ml, 1 strip · UDI-DI 08055182873050

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

Description

The MTS™ Tetracycline 0.016-256 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 μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Tetracycline at concentrations of 0.016-256 μg/mL should be interpreted at 16-20 hours of incubation. Tetracycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Staphylococcus aureus Acinetobacter baumannii Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.