AccessGUDID - DEVICE: Liofilchem Mic Test Strip (MTS) (08055182873050)

GUDID

Device Identifier (DI) Information

Brand Name: Liofilchem Mic Test Strip (MTS)
Version or Model: Tetracycline TE 0.016-256 µg/ml, 1 strip
Commercial Distribution Status: In Commercial Distribution
Catalog Number: $92114-10
Company Name: LIOFILCHEM SRL

Primary DI Number: 08055182873050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 435342134 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JWY	Manual Antimicrobial Susceptibility Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183140	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d4ebb012-0d82-4d46-8cee-57ce86b57f0d
Public Version Date: March 12, 2019
Public Version Number: 1
DI Record Publish Date: March 04, 2019