Liofilchem Mic Test Strip (MTS)

Basic Information

• Brand Name: Liofilchem Mic Test Strip (MTS)
• Primary DI: 08055182873043
• Version / Model: Tetracycline TE 0.016-256 µg/ml, 1 strip
• Catalog Number: $92114-1
• Company Name: LIOFILCHEM SRL
• Labeler DUNS: 435342134
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-04
• Public Version: 1
• Public Version Date: 2019-03-12
• Public Version Status: New
• Public Device Record Key: aca7f99e-2cd1-4824-9ecc-193f72ab4b51

Device 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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37300	Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit	A collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterials against a specific bacterial microorganism, isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28055182873047	GS1	box	30	In Commercial Distribution
Primary	08055182873043	GS1
Package	18055182873040	GS1	box	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K183140	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius