AccessGUDID - DEVICE: Liofilchem Mic Test Strip (MTS) (08055182871704)

GUDID

Device Identifier (DI) Information

Brand Name: Liofilchem Mic Test Strip (MTS)
Version or Model: Ciprofloxacin CIP 0.002-32 μg/mL 10 Strips
Commercial Distribution Status: In Commercial Distribution
Catalog Number: $92045-10
Company Name: LIOFILCHEM SRL

Primary DI Number: 08055182871704
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 435342134 *Terms of Use

Device Description: The MTS™ (MIC Test Strip) Ciprofloxacin 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 μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Ciprofloxacin at concentrations of 0.002-32 μg/mL should be interpreted at 16-20 hours of incubation. MTS™ Ciprofloxacin can be used to determine the MIC of ciprofloxacin against the following bacteria. Ciprofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Gram-negative bacteria Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Serratia marcescens

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 [?]
K183527	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: 866b559c-02f1-4909-a394-8486f2a7ac68
Public Version Date: April 29, 2019
Public Version Number: 1
DI Record Publish Date: April 19, 2019